Pfizer COVID-19 booster shots available for high-risk groups
Community, Press Release September 27, 2021
RALEIGH — To strengthen and extend protections against severe illness, North Carolinians at high risk for serious illness or exposure who have been fully vaccinated with the Pfizer-BioNTech (COMINARTY) vaccine for six months or more can now receive a COVID-19 booster shot.
The Centers for Disease Control and Prevention today announced the Pfizer-BioNTech (COMIRNATY) COVID-19 booster shot is recommended for individuals who have been fully vaccinated for six months or more with the Pfizer-BioNTech vaccine. People who are 65 years or older, 18 years or older with underlying medical conditions or work in a high-risk setting like healthcare workers, teachers and childcare providers or food workers are eligible in North Carolina.
“Pfizer boosters are now authorized for certain groups of individuals to extend the protection of vaccines against severe illness,” said NCDHHS Secretary Mandy K. Cohen, M.D. “If you are eligible, get your booster. If you aren’t vaccinated yet, don’t wait. The COVID-19 virus is more contagious than ever and we are seeing it attack the unvaccinated and make them very sick at an alarming rate.”
Those eligible can find booster shots at their health care provider, pharmacies and other locations where COVID-19 vaccines are available. There is no need for people to go back to the location where they received their original vaccines — most COVID-19 vaccination locations can provide Pfizer boosters. Visit MySpot.nc.gov and check “Pfizer-BioNTech (age 12+)” to search locations and ensure Pfizer is available. The CDC’s decision follows the Food and Drug Administration authorizing boosters for certain populations on Wednesday, Sept. 22.
If you have questions about whether to get a Pfizer booster, NCDHHS encourages you to talk to a medical professional to get their opinion.
North Carolina’s actions are based on recommendations from the CDC. Read the CDC’s full statement here.
NCDHHS encourages everyone 12 and older to get vaccinated against COVID-19 and to continue to practice the 3 Ws — wear a mask, wait six feet apart and wash your hands or use hand sanitizer to protect yourself and others.
If you have questions about Pfizer COVID-19 boosters, you can also join NCDHHS’s upcoming Town Hall featuring Dr. Elizabeth Cuervo Tilson, State Health Director and NCDHHS Chief Medical Officer on Monday, Sept. 27, 5:30-6 p.m. by dialing (855) 756-7520 and entering 76072# when prompted.
Visit MySpot.nc.gov for more COVID-19 information and updates and to find a vaccine location near you.
FDA fully approves Pfizer COVID-19 vaccine
News, Press Release August 23, 2021
Today, 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 Pfizer 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.
Related Information
Immunocompromised People Can Now Receive Additional Dose of Moderna, Pfizer COVID-19 Vaccines
News, Press Release August 16, 2021
RALEIGH — North Carolinians who are moderately to severely immunocompromised and received the Moderna or Pfizer vaccines can now begin receiving an additional dose to better protect themselves from COVID-19, the North Carolina Department of Health and Human Services announced today.
On Thursday, the U.S. Food and Drug Administration amended the Emergency Use Authorizations for both vaccines to allow for the use of an additional dose in some immunocompromised individuals, which was then recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP) on Friday. A full list of conditions can be found on the CDC’s website. People who are moderately to severely immunocompromised make up about 3% of the adult population in the U.S.
According to the CDC, emerging data suggest some people with moderately to severely compromised immune systems do not always build the same level of immunity after vaccination compared to people who are not immunocompromised. In addition, in small studies, fully vaccinated immunocompromised people have accounted for a large proportion of hospitalized post-vaccination cases.
“This additional dose will offer valuable protection to those who need it, especially as we face a surge in COVID-19 cases due to the Delta variant,” said Dr. Elizabeth Tilson, NCDHHS State Health Director and Chief Medical Officer. “I encourage those who are eligible to get this additional dose. In addition, if you are not fully vaccinated, please do so now to protect yourself and others – like those who are immunocompromised – from severe illness, hospitalization and death from COVID-19.”
An additional dose of the same brand of vaccine is recommended for moderately to severely immunocompromised people at least 28 days after they’ve completed their initial two-dose series to help increase the body’s immune response. The same vaccine brand should be used unless unavailable, in which case either Pfizer or Moderna vaccine can be used.
The Moderna vaccine is available to those 18 and older, while the Pfizer vaccine is available to those 12 and older.
Studies supporting this change were specific to people who are moderately to severely immunocompromised and the authorization and recommendation for the additional dose is limited to this population. Additional doses should only be provided to people who are moderately or severely immunocompromised. Patients may self-attest to their medical condition.
Providers can find information from the CDC at Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States.
Immunocompromised people eligible for an additional dose of the Moderna and Pfizer vaccines should contact their health care provider or they can visit MySpot.nc.gov or call 888-675-4567 to find a vaccine location near them. Supply of vaccine in the state can accommodate providing this additional dose for immunocompromised people.
It is not recommended that immunocompromised people who were vaccinated with the Johnson & Johnson vaccine get an additional dose at this time. There is not enough data on the safety and effectiveness of an additional vaccine dose of the Johnson & Johnson vaccine for it to be authorized. This recommendation may change as more data is available.
All unvaccinated North Carolinians age 12 and older are encouraged to get a COVID-19 vaccine to protect against severe illness, hospitalization and death. Rigorous clinical trials in more than a hundred thousand people have proven vaccines are safe and effective. Almost 200 million Americans have received a COVID-19 vaccine. Research has shown even people who had a mild case of COVID-19 may struggle with long-term effects like shortness of breath, chest pain and brain fog.
To help slow the spread of COVID-19 and protect our communities, NCDHHS also recommends that everyone wear a mask in indoor public spaces if you live in area of high or substantial levels of transmission as defined by the CDC until more people are vaccinated and viral transmission decreases. In North Carolina, that is now all 100 counties.
To get a vaccine near you, visit MySpot.nc.gov or call 888-675-4567. You can also text your zip code to 438829 to find vaccine locations near you.