Investing.com - The FDA has recommended approval of the COVID-19 vaccine by Pfizer and BioNTech, which could give the FDA an emergency approval this Friday, The Wall Street writes. Journal.
In a one-day group meeting on Thursday, 17 voted in favor, while 4 voted against (with one abstention).
According to Katrin Jansen, head of vaccine research and development at Pfizer, "the infection is practically out of control and the introduction of the vaccine is urgent."
The members of the commission themselves deliberately made their choice in favor of the drug Pfizer and BioNTech, seeing the preponderance of its advantages over the risk for people aged 16 and older.
"The vaccine's efficacy is tremendous," said Eric Rubin, a Harvard microbiologist, panelist and editor-in-chief of the New England Journal of Medicine. And Ofer Levy, another commissioner and director of the vaccination program at Boston Children's Hospital, agreed with him: "When 2,000 to 3,000 people die from coronavirus a day, the choice is clear to me."
As for those who voted against, their main counterarguments were mainly related to the sample of patients: either it was incomprehensible, or the data on their participation in the trial were presented too late.
For example, according to Archana Chatterjee, dean of the Chicago School of Medicine at the University of Science and Medicine Rosalind Franklin, there was insufficient data to justify the inclusion of adolescents aged 16 and 17 years old in the list of those who will receive vaccinations in case of emergency.
“They are not at high risk,” she said in an interview. “It worried me that the data was very limited for 16 and 17 year olds.” She said she would have cast her vote for vaccination, as for adults the benefits of the vaccine are clear.
And Oveta Fuller, a virologist at the University of Michigan School of Medicine, expressed her disagreement because she received the data on the participants too late: at least they were needed at least two months in advance to determine if the vaccine reduces transmission.
With the approval of the FD vaccine, the path is now open for distribution, which could happen as early as Friday or next weekend, given the scale of the epidemic and the 95% effectiveness of the drug.
While the majority of infectious disease doctors, pediatricians and vaccine specialists supported the authorization of the vaccine in an emergency, there was concern among the members of the advisory group about side effects and reactions to the drug.
The concern, in particular, was due to the fact that two patients who received the vaccine this week in Britain developed allergic reactions. The Commission urged FD and the vaccine developer Pfizer to investigate the issue further.
Katrin Jansen assured the panelists, saying that Pfizer is studying the possibility of protecting a vaccine against asymptomatic coronavirus, and hopes to complete this analysis early next year. Pfizer said during a presentation on Thursday that it plans to apply for full approval of its vaccine through a biological license paperwork by April 2021.
The FDA and other federal agencies will monitor the use of COVID-19 vaccines long after approval, including how long the vaccines will provide immunity.
- In the preparation materials from The Wall Street Journal were used.