WASHINGTON (NEXSTAR) — On Friday morning, Pfizer’s chief executive announced the company wouldn’t apply for emergency authorization of its coronavirus vaccine prior to late November — effectively ending any theory a vaccine could be ready by the November 3 election.
Pfizer says it will need to collect safety and manufacturing data which pushes its timeline to request authorization until the third week of November, at the earliest. Dr. Albert Bourla, the company’s chief executive, said in an online statement that that Pfizer should know in the next couple weeks if its vaccine is effective.
“A committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial,” the statement said.
While it was largely speculated Pfizer couldn’t meet the aggressive timeline, this is the company’s first public statement acknowledging approval can’t happen ahead of Election Day.
Pfizer is one of four companies in late-stage clinical trials testing a vaccine. Moderna, AstraZeneca and Johnson & Johnson had looser timelines saying that later in the year is more likely, according to the New York Times.
Both Johnson & Johnson and AstraZeneca’s trials have been paused at different points due to safety concerns.
Looking globally, Pfizer, Moderna, and Germany’s BioNTech are furthest along in final-stage testing.
Dr. Anthony Fauci, the nation’s top infectious disease expert, has said “the best bet” is that data about whether any of the vaccines work will emerge sometime in November or December.
How soon depends on an independent Data Safety and Monitoring Board — the only group that can peek at the data before the study’s finished. At pre-set time points, the board can analyze the number of infections occurring so far among participants and decide if the study should be stopped early because of strong evidence the vaccine works, or if it’s failing, or that it’s too soon to know.
The DSMB also watches for side effects. Many vaccines cause temporary side effects like fever, chills and other flu-like symptoms.
Looking back at vaccines for other diseases, side effects show up within two to three months, said FDA vaccine chief Dr. Peter Marks.
So FDA told COVID-19 vaccine makers: If they seek “emergency use authorization” to get their shot to market faster than normal, they still would have to track half the participants for two months after the last dose.
Then it would take FDA several weeks of breakneck work to decide if a COVID-19 vaccine really was suitable for emergency use, Marks said. In contrast, evaluating an application for full approval could take months, as FDA officials comb through fuller records of how participants fared.
Once the FDA clears a vaccine, health workers and other essential workers are expected to get the first doses — and they’ll have to sign an agreement to do so that includes their cell number and email. The CDC will use those registrations to check how the vaccinated are feeling.
Any health complaint bad enough that they missed work, couldn’t do a normal activity or had to seek medical care gets a follow-up probe, said CDC’s Dr. Tom Shimabukuro.
Separately, the FDA will be checking giant databases of insurance claims and electronic medical records, to see if people who received vaccine also have an uptick in health care.
And states including New York, Rhode Island and Virginia are forming advisory committees to review the safety of any COVID-19 vaccines that pass FDA.
The Associated Press contributed to this report.
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