FDA Agrees to EUA for COVID-19 Vaccine From Pfizer, BioNTech

The FDA late Friday issued the first emergency use authorization (EUA) for a vaccine to prevent coronavirus disease 2019 (COVID-19), a day after an advisory panel recommended the use of Pfizer and BioNTech’s vaccine

Also Friday, HHS announced it was buying 100 million additional doses of vaccine from Moderna. The Moderna candidate, mRNA-1273, will be heard before the same advisory panel December 17 that heard the Pfizer and BioNTech application Thursday.

The administration previously agreed to buy 100 million doses from Moderna; with 100 million doses from Pfizer, the United States would have 300 million doses. The government also has the option to acquire up to an additional 300 million doses of the Moderna vaccine.

The EUA came at the end of a day in which President Donald Trump chastised FDA Commissioner Stephen Hahn on Twitter, and The New York Times reported that the White House threatened him with the loss of his job if the EUA was not approved on Friday. Previous reports predicted the EUA might happen over the weekend.

Trump called the agency a “big, old, slow turtle” on Twitter, adding: ”Get the dam vaccines out NOW, Dr. Hahn. Stop playing games and start saving lives.”

Hahn has said he would be guided by “science, not politics.”

In the EUA, which was granted to Pfizer, the FDA kept the age for immunization at 16 and older. During the panel discussion Thursday, some questioned whether the vaccine should be limited to those 18 and older, given the low numbers of teenagers in the clinical trials and because most younger people tend to have less serious cases of the disease.

Another topic of discussion at the panel—whether the vaccine should be given to pregnant women—was not addressed in the FDA materials released Friday, except for advising that women discuss the vaccine with their health care provider.

The panel also discussed the 2 anaphylactic reactions that surfaced in Britain this week after vaccinations of health care workers and older adults began; the UK health regulatory agency Wednesday announced that individuals "with a history of anaphylaxis to a vaccine, medicine or food" should not receive the shot after 2 health care workers, both of whom carried epinephrine to treat severe allergic reactions, had anaphylaxis soon after administration.

In the fact sheet for providers, the EUA advises not to give the vaccination "to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component" of the vaccine; it also notes that additional severe reactions may become known as the vaccine becomes more widely used.

Earlier in the week, it was reported that the Trump administration never finalized a deal with Pfizer to secure 100 million additional doses of the 2-dose vaccine, which is given 21 days apart.

Even before the EUA was approved, however, doctors were posting on Twitter Friday that they already had appointments for next week to get vaccinated. Front-line health care workers and residents of nursing homes will be the first to get the shots.

The EUA was issued as public health officials and doctors reported that they are seeing the effects of friends and family socializing over Thanksgiving and issued new, urgent pleading for people to stay home over the rest of the holiday season, The Associated Press reported.

The virus has killed more than 295,000 Americans so far, with close to 16 million infections. With the pandemic continuing to spread unabated, some areas began returning to measures used during the first surge in the spring; both New York and Pennsylvania, for instance, said they would ban indoor restaurant dining in the coming days.