Sandra Lindsay, an ICU nurse at Long Island Jewish Medical Center in Queens, New York, was vaccinated at earlier this morning.
This is what heroes look like.— Andrew Cuomo (@NYGovCuomo) December 14, 2020
Sandra Lindsay, an ICU Nurse at Long Island Jewish Medical Center in Queens, became the FIRST AMERICAN to get vaccinated in a non-trial setting.
Thank you Sandra and thank you Dr. Michelle Chester. #NewYorkToughpic.twitter.com/g4HGZ3jbGG
The FDA granted the Pfizer/BioNTech COVID-19 vaccine EUA in the US on Friday: making it the first COVID-19 vaccine to be authorized in the country. The vaccine was first authorized in the UK on December 2, with vaccination commencing there last week. Pfizer and BioNTech are now working on gathering other regulatory approvals around the globe: Singapore today became the first Asian country to give the jab the green light.
In the US, the vaccine is authorized for use in individuals aged 16+. Two doses are administered three weeks apart. Around 145 US hospitals are expected to receive deliveries of the vaccine today, with more following throughout the week.
Pfizer and BioNTech are now gathering additional data as they prepare to file a Biologics License Application (BLA) with the FDA: eying up possible full regulatory approval in 2021.
First Vaccine Administered. Congratulations USA! Congratulations WORLD!— Donald J. Trump (@realDonaldTrump) December 14, 2020
Stay hopeful — brighter days lie ahead. https://t.co/rEY4b7TGBf— Joe Biden (@JoeBiden) December 14, 2020
EUA authorization: What did the FDA say?
The FDA authorization took into account a number of factors as it assessed Pfizer's mRNA vaccine: including safety, efficacy and manufacturing quality and consistency.
The FDA says the Pfizer/BioNTech application met the criteria set out in earlier guidance documents: including the provision of the required 2 months of safety data from Phase 3 trials: amounting to 37,586 participants in ongoing trials (18,801 of whom received the vaccine and 18,785 of whom received the saline placebo).
Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research, said: “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks.
“Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee.”
The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.
Pfizer has submitted a pharmacovigilance plan to the FDA to monitor the safety of the vaccine. It is required to track and report any serious adverse events and severe cases of COVID-19 following vaccination to the Vaccine Adverse Event Reporting System (VAERS). The Phase 3 participants will also be involved in longer-term safety follow ups.
FDA on efficacy
The FDA notes data from the vaccine’s Phase 3 trials: which reported 95% efficacy. The trial reported eight COVID-19 cases in the vaccine group and 162 in the placebo group. Of these 170 COVID-19 cases, one in the vaccine group and three in the placebo group were classified as severe.
The FDA also notes, however, that “At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.”
Manufacturing and distribution
Pfizer is manufacturing the COVID-19 vaccine at its sites in Saint Louis, Missouri; Andover, Massachusetts; and Kalamazoo, Michigan. Pfizer’s Pleasant Prairie, Wisconsin and Puurs, Belgium sites are also being used.
Pfizer has a deal with the US Government to provide 100 million doses; while Pfizer CEO Albert Bourla told CNN on Monday that the company is in negotiations to provide a further 100 million doses in 2021.
: The first shipment from our Kalamazoo plant. @UPS@FedEx— Pfizer Inc. (@pfizer) December 13, 2020
The Pfizer-BioNTech #COVID19 vaccine has not been approved or licensed by the @US_FDA but has been authorized for emergency use to prevent COVID-19 in individuals 16+. See conditions of use: https://t.co/OS1tgYopUjpic.twitter.com/yogti0Ahcq
The first priority for COVID-19 vaccines in the US is health care personnel treating patients, and residents in nursing homes and other long-term care facilities.
Setting out vaccination priorities earlier this month, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) notes that health care settings and long-term care settings can be high-risk locations for SARS-CoV-2 exposure and transmission. Around 245,000 COVID-19 cases and 858 COVID-19-associated deaths have been reported among U.S. health care personnel this year.
Around 21 million US health care personnel work across settings such as hospitals, care homes, outpatient clinics, home health care, public health clinical services, emergency medical services, and pharmacies.
Care home residents are at high risk of infection and severe illness from COVID-19: because of their age, high rates of underlying medical conditions, and congregate living situation. This year more than 500,000 COVID-19 cases and 70,000 associated deaths have been reported among residents of skilled nursing facilities.
Pfizer/BioNTech vaccine: timeline at a glance
The vaccine, BNT162b2, is a nucleoside-modified messenger RNA candidate.
March 17: Pfizer and BioNTech announce they will co-develop a potential COVID-19 vaccine, using BioNTech’s mRNA-based vaccine candidate BNT162. The project starts with four potential vaccines: building on a 2018 mRNA vaccine partnership for influenza.
July 13: BNT162b2 is granted FDA fast track designation (along with BNT162b1). Later in July, BNT162b2 is selected as the lead candidate and starts Phase 2/3 safety and efficacy trials.
Oct 6: Pfizer and BioNTech initiate rolling submission to European Medicines Agency
November 18: Phase 3 study concluded with 170 confirmed COVID-19 cases in the 43,000 strong trial. The companies report 95% efficacy for the vaccine candidate; and obtain 2 months of safety data as required for a EUA request to the FDA.
November 20: Request for EUA submitted to the FDA.
December 2: The UK becomes the first country to authorize the vaccine
December 8: The first Pfizer/BioNTech vaccine shot is delivered to a member of the public in the UK.
December 10: In the US, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) issues a positive endorsement of the vaccine.
December 11: Vaccine authorized for use in the US under an EUA
December 14: Vaccination starts in the US