The Food and Drug Administration’s panel of advisers on Thursday recommended in a 17-4 vote with one abstention authorized for emergency use that the COVID-19 vaccine developed by Pfizer and BioNTech. The FDA is now expected to determine without delay that there are no safety concerns that would prevent the emergency use of the vaccines developed by these two companies, which have shown to be 95% effective.
Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
The final vote reflected a dispute within the panel over the inclusion of people ages 16 and 17 in the proposed emergency use authorization. Some panelists objected to the inclusion of people younger than 18, suggesting Pfizer has only scant data on the vaccine’s safety in this group. Pfizer’s data included only 153 participants who were 16 and 17 years old.
Hayley Gans, a professor of pediatrics at Stanford University, said during the discussion: “I would support not including them.” But Paul Offit, a pediatrician at Children’s Hospital of Philadelphia, rejected this objection, saying, “We have clear evidence of a benefit. All we have on the other side is a theoretical risk.”
Gans and several other committee members who wanted the teens excluded still voted to recommend the approval of the vaccine. Cody Meissner, a pediatrician at Tufts Children’s Hospital, abstained.
Eventually, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) ruled that based on the totality of scientific evidence available, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 in individuals 16 years of age and older and that the known and potential benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its known and potential risks for use in individuals 16 years of age and older.
The committee recommended that additional studies be conducted by the vaccine manufacturer following the issuance of the Emergency Use Authorization, to gather further data on the safety and effectiveness of this vaccine.
Pfizer and BioNTech issued a press release saying they will “continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to country authorization or approval, to help ensure it can reach those most in need as quickly as possible. The companies are leveraging leading vaccine manufacturing and distribution capabilities to quickly scale, manufacture and distribute large quantities of the vaccine at high quality, complementing the mRNA manufacturing expertise of BioNTech gained over almost a decade.”