Pfizer and German partner BioNTech announced that they will start distributing the first batches of their BNT162b2 vaccine in the US in coming days after the Food and Drug Administration (FDA) authorized its emergence use (EUA) against COVID-19 in patients 16 years of age and older.
The FDA has determined that the COVID-19 vaccine developed by Pfizer (PFE) and BioNTech has met the statutory criteria for issuance of an EUA. The US regulator concluded that the “totality of the available data provides clear evidence that the Pfizer-BioNTech vaccine may be effective in preventing COVID-19.”
Pfizer and BioNTech have previously announced that they have a combined manufacturing network for the potential global supply of up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. In the US, the two companies have secured a $2 billion deal to supply 100 million doses, with an option for 500 million more.
The Pfizer-BioNTech vaccine contains messenger RNA (mRNA), which is genetic material. Specifically, it contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a patient receives the vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. The vaccine is administered in two doses, three weeks apart.
The “emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the US,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. “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.”
The effectiveness data to support the EUA include an analysis of 36,523 participants in the ongoing randomized, placebo-controlled international study, who did not have SARS-CoV-2 infection symptoms through seven days after the second vaccine doses. Among these participants, 18,198 received the vaccine and 18,325 received placebo. The vaccine was 95% effective in preventing COVID-19 disease among the clinical trial participants, with eight COVID-19 cases in the vaccine group and 162 in the placebo group.
However, the FDA noted that data are not available to determine how long the vaccine will provide protection, or if the vaccine prevents transmission of SARS-CoV-2 from one person to another.
Going forward, Pfizer and BioNTech (BNTX) said that they are now working to collate additional data and prepare to file for a planned Biologics License Application (BLA) with the FDA targeting full regulatory approval in 2021.
Meanwhile, Merrill Lynch analyst Geoff Meacham on Friday raised PFE’s price target to $43 from $42, but stuck to a Hold rating, as the analyst remains cautious citing the drugmaker’s patent expirations in the years following 2026.
Shares of Pfizer have surged 12% over the past month, taking the year-to-date gain to 11%. (See Pfizer stock analysis on TipRanks)
From the Street, the stock scores a cautiously optimistic Moderate Buy consensus. That’s based on 4 Buys vs 9 Holds. The average analyst price target stands at $41.77, putting the downside potential at a moderate 1.6% over the next 12 months.
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