New Report on Impact of the COVID-19 Pandemic on People with Disabilities: Research Findings
ACL’s National Institute of Disability, Independent Living, and Rehabilitation Research (NIDILRR) released a report, Impact of the COVID-19 Pandemic on People with Disabilities (PDF). The report highlights examples of key research findings on the impact of the pandemic on people with disabilities as well as available resources from the NIDILRR grantee community.
The report includes findings from studies focusing on specific groups that were particularly hard hit, such as people with intellectual and developmental disabilities, people from marginalized communities, and people with mental health disorders. The report also highlights findings and resources in specific areas of community engagement and participation, rural communities, education services, telehealth, and employment and return-to-work accommodations. Finally, the report identifies research gaps and opportunities for further research.
View additional information and resources related to COVID-19 pandemic from the NIDILRR grantee community.
Statement from HHS Secretary Xavier Becerra: All Adults Are Now Eligible for COVID-19 Booster Shots
On the heels of the FDA and CDC decisions to expand COVID-19 booster shots to all adults, HHS Secretary Xavier Becerra issued following statement:
“All adults are now eligible for COVID-19 booster shots. After thorough review of the data, we are following the science, which shows boosters can help increase people’s protection from COVID-19 and help us reduce infections and severe outcomes. This is especially important ahead of the winter months, where we all spend more time indoors. I am grateful to the hard-working scientists at the FDA and CDC for their rigorous, independent decision-making on booster shots and their ongoing commitment to keeping us all safe.
“As President Biden has said, we are committed to using every tool at our disposal to fight the virus on our path out of the pandemic, and boosters are important for strengthening people’s protection from disease and helping us stave off a worse winter surge. We will continue to pull every lever we have to get all Americans vaccinated, but for the adults who are already vaccinated, you can get your booster six months after your second dose of either Pfizer or Moderna, or two months after your single dose of J&J. Getting a booster can help keep you—and those around you—even safer. If you are eligible, please go to vaccines.gov to find available vaccine near you and schedule your booster appointment today.”
CDC Recommends Pediatric COVID-19 Vaccine for Children 5 to 11 Years
Yesterday, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that children 5 to 11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine. CDC now expands vaccine recommendations to about 28 million children in the United States in this age group and allows providers to begin vaccinating them as soon as possible.
COVID-19 cases in children can result in hospitalizations, deaths, MIS-C (inflammatory syndromes) and long-term complications, such as “long COVID,” in which symptoms can linger for months. The spread of the Delta variant resulted in a surge of COVID-19 cases in children throughout the summer. During a 6-week period in late June to mid-August, COVID-19 hospitalizations among children and adolescents increased fivefold. Vaccination, along with other preventative measures, can protect children from COVID-19 using the safe and effective vaccines already recommended for use in adolescents and adults in the United States. Similar to what was seen in adult vaccine trials, vaccination was nearly 91 percent effective in preventing COVID-19 among children aged 5-11 years. In clinical trials, vaccine side effects were mild, self-limiting, and similar to those seen in adults and with other vaccines recommended for children. The most common side effect was a sore arm.
COVID-19 vaccines have undergone – and will continue to undergo – the most intensive safety monitoring in U.S. history. Vaccinating children will help protect them from getting COVID-19 and therefore reducing their risk of severe disease, hospitalizations, or developing long-term COVID-19 complications. Getting your children vaccinated can help protect them against COVID-19, as well as reduce disruptions to in-person learning and activities by helping curb community transmission.
Distribution of pediatric vaccinations across the country started this week, with plans to scale up to full capacity starting the week of November 8th. Vaccines will be available at thousands of pediatric healthcare provider offices, pharmacies, Federally Qualified Health Centers, and more.
The following is attributable to Dr. Walensky:
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated.”
COVID-19 Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:
The use of a single booster dose of the Moderna COVID-19 Vaccine that may be administered at least 6 months after completion of the primary series to individuals:
65 years of age and older
18 through 64 years of age at high risk of severe COVID-19
18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.
The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death. The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
“The amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We are also taking action today to include the use of mix and match boosters to address this public health need. We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”
Authorization of Moderna COVID-19 Vaccine Booster Dose
To support the authorization for emergency use of a single booster dose of the Moderna COVID-19 Vaccine, the FDA analyzed immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least 6 months after their second dose and compared it to the immune responses of 1,055 study participants after completing their two-dose series. The antibody response of the 149 participants against SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response.
The FDA also evaluated an additional analysis from Moderna comparing the rates of COVID-19 accrued during the Delta variant surge during July and August 2021, which suggest that there is a waning of vaccine effectiveness over time.
Safety was evaluated in 171 participants 18 years of age and older who were followed for an average of approximately six months. The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain at the injection site, tiredness, headache, muscle and/or joint pain, chills, swollen lymph nodes in same arm as the injection, nausea and vomiting, and fever. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.
Ongoing analyses from the FDA and the Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart conditions, myocarditis and pericarditis, following vaccination with the Moderna COVID-19 vaccine, particularly following the second dose. Typically, onset of symptoms has been a few days following vaccination. The observed risk is higher among males under 40 years of age, particularly males 18 through 24, than among females and older males.
The Moderna COVID-19 single booster dose is half of the dose that is administered for a primary series dose and is administered at least six months after completion of a primary series of the vaccine.
Authorization of Janssen (Johnson and Johnson) COVID-19 Vaccine Booster Dose
The authorization for emergency use of a single booster dose of the Janssen COVID-19 Vaccine is based on the FDA’s evaluation of immune response data in 39 participants from a clinical trial including 24 participants who were 18 through 55 years of age and 15 participants who were 65 years of age and older. The study participants received a booster dose approximately 2 months after their first dose, and the results demonstrated a booster response.
Overall, approximately 9,000 clinical trial participants have received two doses of Janssen COVID-19 Vaccine administered at least two months apart and of these, approximately 2,700 have had at least two months of safety follow-up after the booster dose. Janssen’s safety analyses from these studies have not identified new safety concerns.
Earlier analyses from the FDA and CDC safety surveillance systems suggest an increased risk of a serious and rare type of blood clot in combination with low blood platelets following administration of the Janssen COVID-19 vaccine. This serious condition is called thrombocytopenia syndrome (TTS). People who developed TTS after receiving the vaccine had symptoms that began about one to two weeks after vaccination. Reporting of TTS has been highest in females ages 18 through 49 years. In addition, safety surveillance suggests an increased risk of a specific serious neurological disorder called Guillain Barré syndrome, within 42 days following receipt of the Janssen COVID-19 Vaccine.
Authorization of “Mix and Match” Booster Dose
Today, the FDA is also authorizing the use of heterologous (or “mix and match”) booster dose for currently available (i.e., FDA-authorized or approved) COVID-19 vaccines. Following a presentation of clinical trial data from the National Institute of Allergy and Infectious Diseases, the Vaccines and Related Biological Products Advisory Committee’s discussion of information submitted for consideration, along with the agency’s evaluation of the available data, the FDA has determined that the known and potential benefits of the use of a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations.
A single booster dose of any of the available COVID-19 vaccines may be administered as a heterologous booster dose following completion of primary vaccination with a different available COVID-19 vaccine. The eligible population(s) and dosing interval for a heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.
For example, Janssen COVID-19 Vaccine recipients 18 years of age and older may receive a single booster dose of Janssen COVID-19 Vaccine, Moderna COVID-19 Vaccine (half dose) or Pfizer-BioNTech COVID-19 Vaccine at least two months after receiving their Janssen COVID-19 Vaccine primary vaccination.
In another example, Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters (65 years of age and older, 18 through 64 years of age at high-risk of severe COVID-19, and 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2) may receive a booster dose of Moderna COVID-19 Vaccine (half dose), Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine at least six months after completing their primary vaccination.
The agency recognizes that health care providers and COVID-19 vaccine recipients will have questions about booster doses. The individual fact sheets for each available vaccine provide relevant information for health care providers and the vaccine recipients. The agency encourages health care providers to also follow the recommendations that will be provided by the CDC following a meeting of their Advisory Committee on Immunization Practices and formal recommendations signed by the CDC director.
Vaccine Accessibility for Children with I/DD
By Alyssa Hoadley, NACDD Fellow
On September 20th, the Washington Post reported that the Pfizer-BioNTech's vaccine trial for children ages 5 to 11 was shown to be effective. The vaccine is on track to being approved for the use on children as soon as Halloween.
As Pfizer-BioNTech moves closer to having their coronavirus vaccine approved for use on children, it is critical to ensure that vaccine distribution takes into account the needs of children with developmental disabilities. Specifically, children with autism who may be more likely to experience Sensory Processing Disorder (SPD), making them more sensitive to stimuli like bright lights, noises, and smells as well as needle anxiety.
The roll out of any vaccine should ensure that individuals with developmental disabilities have access to clinics that provide a quiet and private space with limited sensory distractions. These clinics should also be staffed with personnel who are knowledgeable in the practices of how to best administer vaccines to children with developmental disabilities. Local and state governments should work with families to ensure that these accommodations are available.
Working to combat vaccination disparities that may be exacerbated due to vaccine hesitation may help close healthcare gaps and establish safer communities for everyone. People who are concerned about accessibility issues should contact their local DD Council or call the Disability Information and Access Line (DIAL) at 888-677-1199.
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
As of Saturday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:
individuals 65 years of age and older;
individuals 18 through 64 years of age at high risk of severe COVID-19; and
individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.
Today’s authorization applies only to the Pfizer-BioNTech COVID-19 Vaccine.
“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic. After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock, M.D. “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”
The Process for Assessing the Available Data
Comirnaty (COVID-19 Vaccine, mRNA), was approved by the FDA on Aug. 23, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. On Aug. 25, 2021, the FDA received a supplement from Pfizer Inc. to their biologics license application for Comirnaty seeking approval of a single booster dose to be administered approximately six months after completion of the primary vaccination series for individuals 16 years of age and older.
As part of the FDA’s commitment to transparency, the agency convened a public meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Sept. 17 to solicit input from independent scientific and public health experts on the data submitted in the application. During the meeting, the vaccine manufacturer presented information and data in support of its application. The FDA also presented its analysis of clinical trial data submitted by the vaccine manufacturer. Additionally, the public was also given an opportunity to provide comment; and FDA invited international and U.S. agencies and external groups, including representatives from the Israeli Ministry of Health, the University of Bristol, U.K. and the Centers for Disease Control and Prevention, to present recent data on the use of vaccine boosters, epidemiology of COVID-19, and real-world evidence on vaccine effectiveness.
The FDA considered the data that the vaccine manufacturer submitted, information presented at the VRBPAC meeting, and the committee’s discussion, and has determined that based on the totality of the available scientific evidence, a booster dose of Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 and that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use. The booster dose is authorized for administration to these individuals at least six months following completion of their primary series and may be given at any point after that time.
It’s important to note that the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine is the same formulation as the FDA-approved Comirnaty and the vaccines may be used interchangeably.
“We’re grateful for the advice of the doctors, scientists, and leading vaccine experts on our advisory committee and the important role they have played in ensuring transparent discussions about COVID-19 vaccines. We appreciate the robust discussion, including the vote regarding individuals over 65 years of age and individuals at high risk for severe disease, as well as the committee’s views regarding a booster dose for those with institutional or occupational exposure to SARS-CoV-2,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision. We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data.”
Data Supporting Authorization for Emergency Use
To support the authorization for emergency use of a single booster dose, the FDA analyzed safety, and immune response data from a subset of participants from the original clinical trial of the Pfizer-BioNTech COVID-19 Vaccine. In addition, consideration was given to real-world data on the vaccine’s efficacy over a sustained period of time provided by both U.S. and international sources, including the CDC, the UK and Israel. The immune responses of approximately 200 participants 18 through 55 years of age who received a single booster dose approximately six months after their second dose were assessed. The antibody response against SARS-CoV-2 virus one month after a booster dose of the vaccine compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response.
Additional analysis conducted by the manufacturer, as requested by the FDA, compared the rates of COVID-19 accrued during the current Delta variant surge among original clinical trial participants who completed the primary two-dose vaccination series early in the clinical trial to those who completed a two-dose series later in the study. The analysis submitted by the company showed that during the study period of July and August 2021, the incidence of COVID-19 was higher among the participants who completed their primary vaccine series earlier, compared to participants who completed it later. The FDA determined that the rate of breakthrough COVID-19 reported during this time period translates to a modest decrease in the efficacy of the vaccine among those vaccinated earlier.
Safety was evaluated in 306 participants 18 through 55 years of age and 12 participants 65 years of age and older who were followed for an average of over two months. The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA for individuals 16 years of age and older. The authorization was expanded on May 10, 2021 to include those 12 through 15 years of age, and again on Aug. 12, 2021 to include the use of a third dose of a three-dose primary series in certain immunocompromised individuals 12 years of age and older. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
The amendment to the EUA to include a single booster dose was granted to Pfizer Inc.
NADSP Statement on Vaccine Hesitancy and FAQ
Since the onset of the COVID-19 pandemic in March 2020, direct support professionals (DSPs) from across the country have played a critical role in helping people with disabilities remain healthy, safe and informed about the virus. To assist DSPs in their work, the National Alliance for Direct Support Professionals (NADSP) has provided a variety of toolkits, resources and webinars with healthcare experts to share timely, trusted and well-researched information. In this vein, we remain committed to inform the direct support workforce and the disability community about the safety and efficacy of available vaccines.
DSPs who support people in their communities are often called upon to make independent judgments on a frequent basis that involve both practical and ethical reasoning. We understand there is continued hesitation among some DSPs about taking the COVID-19 vaccine, and we hope the recent full FDA approval of one of the main vaccines on the market helps calm these fears.
As NADSP’s Code of Ethics outlines, a DSP must commit to promoting the emotional, physical, and personal well-being of the people they support. DSPs must encourage personal growth and recognize the autonomy of individuals with disabilities receiving support while also being proactive and vigilant in protecting public health. To maintain the promise of partnership and respect that must exist in a supportive relationship, a strong ethical foundation is critical to help DSPs navigate through the maze of influences that bombard them around COVID-19 and available vaccines.
We understand that being vaccinated is a major health-related decision and requires research, information and examination. Furthermore, DSPs are entrusted to support people with disabilities in making their own informed decisions based on the associated risks and responsibilities that are tied to those decisions.
The following ideals and practices of informed decision-making will be useful to all who remain hesitant to vaccination.
Make every effort to understand the health issues and current situation regarding COVID-19 and the available vaccines.
Gather all the pertinent information about COVID-19 and available vaccines from credible sources to help with your decision. Always consult with your healthcare professional if you need more information.
Explore the options and consider the outcomes of getting or not getting a vaccine.
Act and make a decision based on factual information and science.
Monitor and evaluate your decision.
The COVID-19 pandemic has impacted essentially every country across the globe, and all nations continue to fight the spread of this virus. Scientific evidence has clearly shown that the various COVID-19 vaccines, coupled with ongoing masking, handwashing, and social distancing practices offer significant protection from the virus and represents an opportunity to finally alter the course of this pandemic. The United States is fortunate to be a nation with widespread access to these important vaccines.
NADSP has compiled a list of common questions and answers to assist DSPs in continuing to make informed decisions about their own health practices pertaining to COVID-19 prevention and in supporting people with disabilities during this time of uncertainty. This resource will be updated as frequently as is needed to get timely, accurate information into the hands of DSPs. You are more than essential workers in this fight – you are the backbone of the disability service sector and the catalysts for helping individuals with disabilities live fully inclusive lives in their communities.
To view and download the full statement and DSP COVID-19 Vaccine FAQs, click here.
FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health
On August 23rd, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."
FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.
Interim Public Health Recommendations for Fully Vaccinated People Updates: July 27, 2021
Summary of Recent Changes
Updated information for fully vaccinated people given new evidence on the B.1.617.2 (Delta) variant currently circulating in the United States.
Added a recommendation for fully vaccinated people to wear a mask in public indoor settings in areas of substantial or high transmission.
Added information that fully vaccinated people might choose to wear a mask regardless of the level of transmission, particularly if they are immunocompromised or at increased risk for severe disease from COVID-19, or if they have someone in their household who is immunocompromised, at increased risk of severe disease or not fully vaccinated.
Added a recommendation for fully vaccinated people who have a known exposure to someone with suspected or confirmed COVID-19 to be tested 3-5 days after exposure, and to wear a mask in public indoor settings for 14 days or until they receive a negative test result.
CDC recommends universal indoor masking for all teachers, staff, students, and visitors to schools, regardless of vaccination status.
Key Points
The following recommendations apply to non-healthcare settings. For related information for healthcare settings, visit Updated Healthcare Infection Prevention and Control Recommendations in Response to COVID-19 Vaccination.
Fully vaccinated people can:
Participate in many of the activities that they did before the pandemic; for some of these activities, they may choose to wear a mask.
Resume domestic travel and refrain from testing before or after travel and from self-quarantine after travel.
Refrain from testing before leaving the United States for international travel (unless required by the destination) and refrain from self-quarantine after arriving back in the United States.
Refrain from routine screening testing if feasible.
Infections happen in only a small proportion of people who are fully vaccinated, even with the Delta variant. However, preliminary evidence suggests that fully vaccinated people who do become infected with the Delta variant can spread the virus to others. To reduce their risk of becoming infected with the Delta variant and potentially spreading it to others: CDC recommends that fully vaccinated people:
Wear a mask in public indoor settings if they are in an area of substantial or high transmission.
Fully vaccinated people might choose to mask regardless of the level of transmission, particularly if they or someone in their household is immunocompromised or at increased risk for severe disease, or if someone in their household is unvaccinated. People who are at increased risk for severe disease include older adults and those who have certain medical conditions, such as diabetes, overweight or obesity, and heart conditions.
Get tested if experiencing COVID-19 symptoms.
Get tested 3-5 days following a known exposure to someone with suspected or confirmed COVID-19 and wear a mask in public indoor settings for 14 days after exposure or until a negative test result.
Isolate if they have tested positive for COVID-19 in the prior 10 days or are experiencing COVID-19 symptoms.
Follow any applicable federal, state, local, tribal, or territorial laws, rules, and regulations.
People who are immunocompromised should be counseled about the potential for reduced immune responses to COVID-19 vaccines and to follow current prevention measures (including wearing a mask, staying 6 feet apart from others they don’t live with, and avoiding crowds and poorly ventilated indoor spaces) regardless of their vaccination status to protect themselves against COVID-19 until advised otherwise by their healthcare provider.
NACDD Introduces Get Out the Vaccine Campaign for Individuals With I/DD
By Donna Meltzer, NACDD CEO
Despite strong efforts across the nation, too many Americans — including people with I/DD, their families and their caregivers — either remain hesitant or are experiencing barriers that keep them from getting the COVID-19 vaccine.
Low vaccination rates have a significant impact on the people we serve at the NACDD. Individuals with I/DD have been living at high risk since the pandemic began. Because so many of these individuals manage co-occurring conditions, this vaccine could save lives — but only if we can get factual information and support into their communities to improve vaccination rates.
Getting factual vaccine information into the I/DD community
When the COVID-19 vaccine was first introduced, there weren’t a lot of materials that spoke to its safety for individuals with I/DD. To build vaccine confidence, we surveyed our DD Councils and reviewed surveys by other partners such as the American Association on Health & Disability to better understand hesitations. The results showed us that most people want to hear from individuals who look like them before making the decision to get vaccinated. This includes not just hearing from individuals with disabilities, but specifically people with disabilities who are also Black, Hispanic, American Indian and Alaska Native (AIAN).
With this in mind, we launched our Get Out the Vaccine campaign, which provides factual, vetted information to individuals with I/DD, their families and their caregivers. We partnered with the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and other trusted resources to offer science-based research that answers common vaccine questions. The campaign uniquely features people who have already made the decision to get vaccinated, including individuals with I/DD, direct support professionals (DSPs), caregivers and others who have high contact with individuals with I/DD.
Individuals with I/DD often require care in their home, which increases their exposure to the virus. Anecdotal data suggests that close to half of DSPs are hesitant to get the vaccine for a variety of reasons, including feeling that they are immune because they have already tested positive for COVID-19, cultural or family beliefs, lack of trust in the government and a lack of trust in the vaccine’s emergency use authorization. Our partnership with the National Alliance for Direct Support Professionals helped us identify barriers that have kept these professionals from getting vaccinated. Because many DSPs are immigrants, it’s important that we improve access to culturally sensitive research and information in a wide range of languages to help this critical support system learn more about the vaccine.
Partnerships strengthen vaccine campaign
We have established our Get Out the Vaccine campaign as a trusted place for people in and supporting the I/DD community to learn about the COVID-19 vaccine. This is due in large part to the strong partners promoting the campaign, including the Administration for Community Living (ACL), the CDC and the White House. Our partnership with the White House connected us with the Made to Save campaign, a national campaign focused on local activities (e.g., popup vaccine clinics) that are breaking down barriers to help people get vaccinated.
A large focus of our Get Out the Vaccine campaign is highlighting intersectionality. For example, a person with an I/DD might also identify as Black, Indigenous or a person of color (BIPOC), which often means they have additional barriers or concerns that have prevented them from getting in line for the vaccine. The campaign aims to address these concerns, while the Made to Save campaign helps people take the next step by providing easy access to vaccine events.
Managed care plays a large role in protecting I/DD populations
Our DD Councils work with UnitedHealthcare Community & State and other managed care organizations (MCOs) across the nation to help individuals with I/DD enroll in Medicaid waivers to get the care they require. We all witnessed the unfortunate rise of deaths in institutional settings at the beginning of the pandemic. MCOs make it possible for many of the people we serve to live in a setting of their choosing in their community, ultimately avoiding similar tragedies and helping individuals live a more self-determined life.
Since the rollout of the COVID-19 vaccine, MCOs have also been instrumental in getting information out about the vaccine and bringing the vaccine into communities. As COVID-19 vaccines are developed for children as young as two, our collaborations with MCOs will grow in importance as we find new ways to communicate with parents of children with I/DD, many of whom will want to discuss the vaccine’s safety and efficacy with their child’s care provider.
We couldn’t have launched this campaign without our strong partnership with UnitedHealthcare Community & State. They have helped connect us with individuals to feature in the campaign, and the team’s support has helped us raise awareness to gain new, influential partnerships. At the end of the day, we want individuals in the I/DD community to choose whether to get vaccinated based on what is best for their health — but first, we want them to have access to all of the facts.
FDA Coronavirus (COVID-19) Update: July 13, 2021
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
Today, the FDA is announcing revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination. GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness, or in the most severe cases, paralysis. Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports of GBS following vaccination with the Janssen vaccine after approximately 12.5 million doses administered. Of these reports, 95 of them were serious and required hospitalization. There was one reported death. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder. GBS has also been observed at an increased rate associated with certain vaccines, including certain seasonal influenza vaccines and a vaccine to prevent shingles. Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship. No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines. FDA continues to work with its partner in vaccine safety surveillance, the CDC, to monitor reports of GBS following vaccination with the Janssen COVID-19 Vaccine. Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks.
The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about GBS and the Fact Sheet for Recipients and Caregivers has been revised to include information about GBS. The warning in the Fact Sheet for Healthcare Providers Administering Vaccine notes that reports of adverse events suggest an increased risk of GBS. Additionally, the Fact Sheet for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine: weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing or swallowing; double vision or inability to move eyes; or difficulty with bladder control or bowel function.Today the agency authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. To date, a total of five batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.
The FDA Center for Drug Evaluation and Research has published a From Our Perspective on the FDA’s Clinical Methodologies Group’s recent U.S. Department of Health and Human Services (HHS) award, which will fund expansion of the CURE ID platformExternal Link Disclaimer. The platform will allow automated anonymized data collection from electronic health records and clinical disease registries for COVID-19 and other difficult-to-treat infectious diseases. This work may facilitate the clinical, research, and regulatory communities to identify signals of potentially safe and effective COVID-19 therapies that may also be candidates for additional study in randomized clinical trials. In the future, CURE ID’s expansion will also include a platform for patients with long COVID to upload information on their treatments, in addition to the treatment outcomes they consider most important.
As part of the FDA’s effort to protect consumers, the agency issued a warning letter to one network operating two websites, www.premierdream.com and www.eirmed360.com, for marketing unapproved drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
Testing updates:
As of today, 396 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 282 molecular tests and sample collection devices, 85 antibody and other immune response tests and 29 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
The FDA has authorized 11 antigen tests and seven molecular tests for serial screening programs. The FDA has also authorized 572 revisions to EUA authorizations.
Related Information
GOTVaccine: Hawaii’s Advocate-Driven Success
By Daintry Bartoldus, Executive Administrator, Hawaii State Council on Developmental Disabilities
Hawaii is the home of ALOHA and OHANA. A place where living in harmony, compassion and mutual understanding of respect is the essence of our culture. So, when the National Association of Councils on Developmental Disabilities (NACDD) debuted the Get Out The Vaccine (GOTVaccine) website and called upon people to be informed and learn more about the COVID-19 vaccines – The Council was ready.
Yet in their “talk story” sessions with caregivers, paid support staff, friends, family members and the community they learned there was a lot of fear and concern over taking the vaccine. People saw in the media the severe side effects of the vaccine in the Philippines and other countries. Caregivers were worried about the individuals who resided in their homes. They felt a great sense of responsibility to care, protect and keep them safe and healthy.
Not deterring from their charge, the Council got to work! They turned to their dedicated staff and community partners including Hawaii’s largest advocacy group for people with intellectual and developmental disabilities (I/DD) - the Hawaii Self-Advocacy Advisory Council (SAAC).
“It’s our role as the advocacy agency for our State to help our community to understand and be informed in decision that affect the lives of individuals with I/DD,” said Daintry Bartoldus, Executive Administrator of the DD Council. “Having information presented in a way that helps people understand and use the information to make informed decisions is how we help each self-advocate exercise their right to choose.”
As more SAAC members shared their stories and the desire to have the life they once had back, the Council heard their voices and acted!
They assigned a staff to research and compile information on the vaccines that were being used in other countries versus the vaccines coming to Hawaii. They began an awareness campaign by offering informational webinars to help people make informed decisions based on the facts not fears.
In time, caregivers were advocating for and supporting the vaccine movement while the advocates continued to Lead by Example and pave the way as community leaders.
Bathey Fong, SAAC President stated, “I wasn’t sure if I wanted to take the vaccine, but I thought about all the important things in my life. I learned about the vaccine from the DD Council and the people who care about me. I decided to take the vaccine and feel happy I did.”
The Council worked on an infographics campaign about taking the vaccine called “This Is My Why”. This has led self-advocates to share their experience in exercising their right to have a voice, choice, and stay healthy.
CDC Director Statement on Pfizer’s Use of COVID-19 Vaccine in Adolescents Age 12 & Older
“Today, I adopted CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation that endorsed the safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccine and its use in 12- through 15-year-old adolescents. CDC now recommends that this vaccine be used among this population, and providers may begin vaccinating them right away.
Though most children with COVID-19 have mild or no symptoms, some children can get severely ill and require hospitalization. There have also been rare, tragic cases of children dying from COVID-19 and its effects, including multisystem inflammatory syndrome in children, or MIS-C.
This official CDC recommendation follows Monday’s FDA decision to authorize emergency use of this vaccine in 12- through 15-year-old adolescentsexternal icon, and is another important step to getting out of the COVID-19 pandemic, and closer to normalcy.”
Be sure to check out the full statement from the CDC here!
I'm not going to waste my (covid-19) shot: My Experience
By Rafael Rolon-Muniz, NACDD Communications and Program Coordinator
On May 1st, I got my second COVID-19 dose. When I walked out of the clinic, I exhaled and looked up at the clear sky. More than a year ago, the United States and its territories went into lockdown and all our worlds were turned upside down.
Many have lost their jobs, restaurants have closed, and countless families lost loved ones with no opportunity to say goodbye. Waking out of the clinic, I thought of my grandparents in Puerto Rico, my parents in Austin, my best friend in Miami. I thought of my girlfriend who has not been able to hug her mom since last year because they are both immunocompromised. Getting the vaccine in no way means we are clear and free; but it is truly a leap in a journey that has taken countless steps to get where we are right now. Sitting in the car, I teared up. I thought after months of wearing masks, we will be able to see each other smile again; we will be able to laugh and hang out with our friends until the sun rises; and we will be able to hug our loved ones. There was never a doubt in my mind that I was going to get the COVID-19 vaccine, but I know some people may be unsure for themselves.
Unfortunately, because of that fear, I was able to get my first shot in April. My girlfriend went to go see her PCP for a check-up. There, her doctor asked why she had not received the shot after recovering from pneumonia back in February. At the time, we were told she was not a priority so we were waiting for public sites to open so that we could both register for an appointment. The doctor listed the reasons why she should have received the shot and registered through the clinic in case any vaccines became available during the week. Remarkably, only four hours later, she got a call saying there was a vaccine available if she got to the clinic before closing. Without hesitation, she drove over, and I met her there. As I was waiting outside, she asked the nurse if there was any chance, I could possibly get a shot. The nurse said there may be one-shot available, but it depended on if the person who was already there did not want it.
When she texted me that, honestly, my heart sank. Sure, I want to get the vaccine, I want to be able to protect my family and those I care about. I also thought of that person, and I assume the person did so as well, or else he would not have even shown up. I only responded: “I hope he gets it.” I wanted that person to get the vaccine for the sake of his family and loved ones. I also thought that if he got it, it meant that the community would be safe. More vaccinations meant that everyone would be less likely to get sick. The bottom line is, the goal should just be that everyone gets it, no matter where in the line you are. In the end, the nurse said he decided not to get it because he was afraid of the vaccine and just walked out. Because of that, I was able to get the vaccine. To this day I am torn, I am glad I was able to receive the vaccine, but I hope he changed his mind and decided to come back and get vaccinated.
For me, the vaccination was a little painful, I will not lie. But what it does, and what it provides is immeasurable. I am aware that moving forward, our lives will be pre-covid and after-covid. We all have our reasons for wanting to get the vaccine; to travel, to see loved ones, to stop wearing masks at a grocery store, to stop the spread; everyone has their reason. I am not here to tell you to go get the vaccine, and the intention is not to repeat the facts. I want to share my reason for getting it and what I look forward to someday: I want to go tubing with my parents in Austin, host a BBQ with my friends, and lie on a beach in Puerto Rico. But more importantly, I want to see all my loved ones smile again in person.
“Why get vaccinated?” Voices from the Community
Sydney Krebsbach, member and advocate, Alaska Developmental Disabilities Council
I have to admit when the vaccine first came out in December, I was against it because I'm horribly afraid of shots. They freak me out, I shake and cry and scream once the needle goes in my skin. At the time, I told my employer my fears and that I wasn't going to get it. Then in February my workplace changed the mitigation plan saying all employees have to get vaccinated in order to return to the office. So, I finally signed up to get the vaccine for Saturday March 20th along with my parents. My autism and anxiety were sky high all week. I talked with my doctor about my anxiety and how to help. But then I realized that I have to do this because not only am I saving my life, but I am saving other people’s lives from getting COVID. Plus, I had my parents there to help me get through it. I didn’t let my autism and anxiety get in the way of saving tons of people's lives!
So this my experience with the COVID vaccine I'm getting my second shot in April!
Emmanuel Jenkins, counselor and business owner. Emmanuel also works for the Delaware Developmental Disabilities Council.
Emmanuel, a Black man with cerebral palsy, has personal experience with making the decision about the COVID-19 vaccine. He had been firmly set against getting vaccinated due to lack of trust. “The first thing that really made me consider it was being a person that lives independently. In order for me to get home-based community-based services, people had to come in and help me out to do those daily living things. So, really realizing that, as I protect myself, then I am also protecting my son, who just turned 13. I am protecting my wife who is very active in the community.”
Elizabeth Joseph, board member, Alaska Developmental Disabilities Council
Elizabeth was concerned about the vaccine because of what she was seeing on social media. She turned to physicians she trusted to get information. “I learned how safe it was, and asking questions really helped me a lot. I grew more confident and comfortable with receiving the vaccination. It was my choice to receive it.” Elizabeth’s family was inspired to get the vaccine as well when it became available. Relying on trusted information and family helped her make her decision.
Dr. Rick Rader, National Medical Director, National Alliance for Direct Support Professionals
COVID-19 has affected Dr. Rader’s work, but also his personal life as he tested positive for COVID-19 and then later got vaccinated. Rick knows how important DSPs are to the I/DD community, and he champions the need for more awareness for DSPs, those they care for, and their own families. While vaccines are not new, there are some questions that people have about the COVID-19 vaccines.
“I like to use this example of getting your car registered at the motor vehicle department. The entire process takes about 5 minutes, but you could be waiting in line for hours. Now, imagine if instead of 5 clerks they had 50 clerks, your time would be cut to 5 minutes or less. And that was the same idea adopted by the FDA, the Food and Drug Administration, which is the federal agency responsible for testing not only vaccines but all new medications to make sure they are not only safe but also efficacious, meaning that they work.”
COVID and Me
Santa E. Perez is a published author of “Sitting at Eye Level: My Life As An Advocate” and is an accomplished advocate. She currently serves as Chair of the Nevada Governor’s Council on Developmental Disabilities
2020 has been a hard year for everyone. The word pandemic was only a word that was a far-fetched event that was written in history books. The unknown was scary and unpredictable. At first, it was only a rumor, then it was a concern that turned into shutdowns, which lead to far too many heartbreaks. And where do people with developmental disabilities and intellectual disabilities fit in all this? We are the largest minority group in the world, but when it comes to a global pandemic I, and many people like me, will be last on the human totem pole. The lack of information or direction was mute. We, who need support just to live were “quarantined”. We worried about the DSPs, who care for us each day, and the people we love.
I have Cerebral Palsy and asthma and I am Hispanic. I am not over 65 (yet), but one of the biggest reasons I wanted the vaccine was because of my asthma. I knew if I contracted Covid-19, it would be bad for me (and people like me). I know that if I would have gone to the hospital, they would have looked at me differently. They would look at my power wheelchair, the way I speak, the amount of care I need, and redeem me as, unusable, less than, unworthy of care. They would not see my value! A well-educated advocate who is well known in the disability community, A mom, and an author
Then finally, some signs of hope, but even with three vaccines that are available now, we still must fight our way to be in line. I can’t wait for the day when my community will become one greater minority group that is included in society. I think when we say Inclusion for all, that means the good and the bad. We are all going through the same things as everyone else: fear, depression, financial problems, etc. DD Councils are at the forefront of revealing the greatness of the disability community and its importance in The American Tapestry
I think about my disability ancestors who fought for our rights to be free. We have come so far and continue to break even more boundaries. We are pushing through the forefront to let our voices be heard, making our ancestors proud. Developmental Disability Awareness Month (DDAM) is a salute to them. I am proud to be a part of this community.