The U.S. Food and Drug Administration (FDA) Friday night approved use of the Pfizer Covid-19 vaccine under an emergency use authorization. This cleared the way for shipments of the initial supplies of the vaccine to begin to various locations around the U.S. so that widespread vaccinations can begin in a few days.
While the issuance of the EUA allows use of the vaccine, it does not constitute full approval, which must await the results of additional testing and the study of additional data.
The FDA’s issuance of the EUA followed by one day the recommendation of an FDA advisory committee to moe ahead with making the vaccine available for use in the U.S. The panel voted 17-4 with one abstention to recommend that the FDA issue the EUA for the Covid-19 vaccine developed by Pfizer in partnership with BioNTech Manufacturing GmbH ad.
The FDA”™s Vaccines and Related Biological Products Advisory Committee, made up of independent scientific and public health experts from around the country, decided that based on the totality of scientiifc evidence available, the benefits of the Pfizer-BioNTech Covid-19 vaccine outweighed its risks for use in individuals 16 years of age or older.
In addition to hearing from the public and representatives of various organizations, the committee received a presentation from Pfizer researchers who gave a detailed analysis of clinical trial data on the vaccine.
“Even though the process has been expedited in association with the review of this EUA, the FDA”™s expert review staff has reviewed thousands of pages of technical information,” FDA Commissioner Stephen Hahn said. “These data include, but are not limited to clinical trial data, nonclinical data on the development of the vaccine in the lab and manufacturing data on how the vaccine is made.”
The final decision on issuing the EUA was made by FDA career officials at in its Center for Biologics Evaluation and Research and ratified by Hahn.
“We recognize the urgent need for medical countermeasures to diagnose, treat and prevent this novel virus and have been working diligently to facilitate their development and availability. In particular, the FDA has been working tirelessly with public and private sectors to facilitate the rapid development of Covid-19 vaccines without sacrificing our rigorous scientific standards for safety and effectiveness,” Hahn said.
Kathrin Jansen, senior vice president and head of vaccine research and development at Pfizer, which has its global vaccine research and development headquarters in Rockland County, had addressed the committee hearing.
“Tens of millions of people have been affected globally and over 1.5 million people have already died. No one is safe from this disease and certain groups such as health care workers and first responders, the elderly with underlying diseases are at particularly high risk. We need a safe and efficacious vaccine to stem this devastating pandemic while also deploying other prevention strategies such as infection control including mask wearing and social distancing.”
Nissa Shaffi, of the National Consumers League, pointed out that there were cases reported in Great Britain of people who have severe allergies experiencing adverse reactions after receiving the vaccine.
“We call on the FDA to heed these warnings and to continue to sustain its robust interagency collaboration towards the evaluation, approval and distribution of the Covd-19 vaccine. Consumers will rely on ongoing guidance from public health agencies regarding potential adverse events from the vaccine,” Shaffi said.
Dru West of the USA Patient Network said that every patient receiving the Covid vaccine needs to know the answers to basic questions such as whether the vaccine will prevent the most serious symptoms or spread of the disease and what side effects or problems might occur immediately, midterm and long term.
“It”™s our opinion that at this time there are too many unanswered questions regarding the safety and efficacy to release the vaccine,” West said.
Sarah Christopherson of the National Women”™s Health Network applauded the FDA for its work but expressed concerns about moving ahead with an approval until various communities, such as the Black community that has been disproportionately affected by the coronavirus, have confidence that the vaccine is safe and effective for them.
“The efficacy data submitted to this panel includes fewer than 2,000 Black and or African-American vaccine recipients and just 131 American Indian or Alaska Native recipients not counting the placebo control population. The safety data included just 206 Black seniors 65 or older and just 131 American Indian or Alaska Native people of any age,” Christopherson said.
It is reported that Connecticut is due to receive 32,200 doses of the Pfizer vaccine in the initial shipment, with New York due to receive 170,000 doses.
Gov. Andrew M. Cuomo said Wednesday that New York the state could receive its initial Pfizer vaccine allocation as soon as this weekend. Just over 42% of the doses will be allocated to New York City. The mid-Hudson region is due to receive 19,200 doses from the first shipment.
“The way the vaccine is going to work is the federal government will be responsible for the procurement and the distribution. The military is doing the transportation with private companies, and they will send it where we ask them to send it. We then set the priorities for not only where it goes, but who gets it,” Cuomo said.
Nursing home residents, nursing home, staff high-risk health care workers, EMS and other health care workers and other essential workers will be first to receive vaccinations. Next in line would be the general population, starting with those who are at higher risk.
The New York National Guard has been selected by the Department of Defense for one of 16 pilot programs to vaccinate military personnel. Members of the New York Army and Air National Guard who serve as part of the state’s Covid response efforts will be among the first to be offered the vaccine.
