THE NEUTRAL ZONE
A coronavirus vaccine may be ready in the third week of November, according to Pfizer Chairman and CEO Albert Bourla. If a vaccine emerges by year’s end, limited doses will likely be available right away and the U.S. government will decide who is first in line. The approval timeline goes against President Donald Trump’s promises of a COVID-19 vaccine before Election Day.
In an open letter, Bourla addressed the public’s concern and confusion regarding the vaccine timeline and emphasized the importance of accumulating the correct number of trials prior to full release. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” he wrote.
The vaccine candidate from Pfizer and BioNTech is one of the farthest along in its development when compared with those produced by AstraZeneca PLC, Moderna Inc. and Johnson & Johnson. AstraZeneca’s trial was placed on hold in early September after a U.K. participant experienced a serious adverse reaction. U.K. trials have since resumed, though U.S. trials remain on hold. Johnson & Johnson also paused its trial.
The U.S. Food and Drug Administration requires the collection of two months of safety data on half the trial participants following a final vaccine dose. When the restrictions were approved in early October, Trump said on Twitter, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”
Pfizer Says It Won’t Seek Vaccine Authorization Before Mid-November – The New York Times – 10/16/2020
Close watchers of the vaccine race had already known that Pfizer wouldn’t be able to meet the requirements of the Food and Drug Administration by the end of this month. But Friday’s announcement represents a shift in tone for the company and its leader, who has repeatedly emphasized the month of October in interviews and public appearances.
Dow jumps on retail rebound, coronavirus vaccine progress – Fox Business – 10/16/2020
Pfizer Inc. said it could apply for emergency use of its experimental COVID-19 vaccine being co-developed with BioNTech SA as soon as the third week of November – once it has received at least two months of safety data as required by the Food and Drug Administration. The company had previously said the data might be ready even sooner — in October. In other vaccine news, Gilead Sciences Inc. is disputing a World Health Organization study that found its antiviral drug remdesivir had “little or no effect on mortality” of hospitalized COVID-19 patients.
Who Decides When Vaccine Studies Are Done? Internal Documents Show Fauci Plays a Key Role. – ProPublica – 10/16/2020
According to a draft charter spelling out how most of the advanced COVID-19 vaccine trials will be monitored, Fauci is the “designated senior representative” of the U.S. government who will be part of the first look at the results. That puts Fauci in the room with the companies — including Moderna, Johnson & Johnson and AstraZeneca — in deciding whether the vaccines are ready to seek approval from the Food and Drug Administration. […] Fauci doesn’t have the same hands-on role for the vaccine that seems poised to show results soonest: Pfizer’s.
Pfizer CEO: We can’t pursue COVID-19 vaccine approval until late November – The Washington Times – 10/16/2020
The Food and Drug Administration is demanding two months of safety data on half of trial enrollees following their final dose, so the pace of Pfizer trial pushes any approval closer to Thanksgiving. […] The upshot is the U.S. could roll out a vaccine before the end of the year, inoculating health care workers and first responders first.