The FDA is expected to officially give the Johnson & Johnson COVID-19 an emergency use authorization (EUA) today after the agency’s Vaccines and Related Biological Products Advisory Committee voted unanimously Friday (Feb. 26) to recommend the authorization.
The FDA issued a statement late yesterday from Acting Commissioner Janet Woodcock, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research that said the agency “has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.” The statement said the agency had also notified “federal partners” about the EUA so they can “execute plans for timely vaccine distribution.”
The CDC has scheduled an emergency meeting of its Advisory Committee on Immunization Practices to start tomorrow (Feb. 28) at 11 a.m. to consider and vote on the J&J vaccine (the FDA and CDC refer to the J&J vaccine as the Janssen vaccine; Janssen is a subsidiary of J&J).
The single-dose vaccine will be the third vaccine available in the U.S. The EUA for the J&J vaccine will not only increase the supply of COVID-19 vaccine in the U.S. but at lower cost. According to what has been reported in various news outlets, J&J is selling its vaccine to the federal government at $10 a dose. The federal government has paid between three or four times more than that for two-dose Pfizer-BioNTech and Moderna vaccines.
The rollout of the COVID-19 vaccines seems to be speeding up. As of yesterday (Feb. 26) the CDC’s COVID-19 vaccine tracker showed that about 75% of the vaccine doses that have been delivered (90,300,910) have been administered (70,454,064).
The CDC’s tally shows that more of the Pfizer-BioNTech vaccine has been administered than the Moderna vaccine.
The Pfizer-BioNTech and Moderna vaccines are both mRNA vaccines but the Pfizer-BioNTech has had disadvantage (largely overcome, it seems) of needing to be stored in special, ultra-cold freezers that keep it at a temperature of between minus 80 degrees to 60 degrees Celsius (minus 112 degrees to 76 degrees Fahrenheit). But on Thursday (Feb. 25) the FDA announced that it was OK to keep the Pfizer-BioNTech at standard freezer temperature for two weeks. Here is exactly what the revised guidance says:
It would surprise no one that Moderna’s revenues increased in 2020 relative to 2019. But on
Thursday (Feb. 25), company officials revealed by how much — and the increase is pretty stunning.
The company’s total revenue in 2019 was $60 million. A pandemic happens, the company develops a COVID-19 vaccine and total revenues in 2020 shoot up more than 13 times, to $803 million. The company’s stock price increased about sixfold from the end of February 2020; it closed at $154.81 on Friday (Feb. 26).
Speaking of Moderna, the company announced in a press release Wednesday (Feb. 24) that it had completed manufacture of a version of its approved mRNA vaccine that is designed to combat the variant of the SARS-CoV-2 virus that emerged in South Africa.
The company said the modified vaccine, named mRNA-1273.351, had been shipped to the NIH in anticipation of starting a phase 1 trial.
The tweaked vaccine may be used by itself as booster or combined into a single dose along with the company’s previously authorized vaccine, which goes by the codename mRNA-1273. Moderna is calling that combined, “multivalent booster” mRNA-1273.211.
Moderna’s announcement says it also plans to evaluate mRNA-1273.351 and mRNA-1273.211 as a primary vaccination series.
Pfizer and BioNTech announced on Thursday that they are evaluating tacking on a third dose to the two-dose regimen as way of fending off the variants. “We believe that a third dose at six months…will raise the antibody response tenfold to twentyfold,” Pfizer CEO Anthony Bourla said interview with NBC’s Lester Holt on Thursday.
But Pfizer also had some interesting news this week about the effectiveness of a single dose of its vaccine. Results of a large study conducted in Israel showed that after a two weeks, a single dose of Pfizer-BioNTech COVID-19 vaccine is 62% effective at preventing severe cases of the disease.
The findings reported in the New England Journal of Medicine Wednesday (Feb. 24) showed that two doses are considerably more effective than a single dose. Still, the effectiveness of the one dose might (this is still very speculative) seed some notions of a short-term single-dose strategy for the Pfizer-BioNTech vaccine as the pandemic goes on, particularly now with the single-dose J&J vaccine coming on the U.S. market.
More conservatively, the data may argue for a longer interval between the two doses because the single dose affords some protection. A longer interval could speed vaccination and achieve herd immunity faster but it may also mean that more people won’t come back for a second dose.
The results reported in NEJM were based on a large study of members of Clalit Health Services, the largest of Israel's health services organizations. The researchers matched 596,618 vaccinated members to the same number of unvaccinated members to assess the effectiveness of the vaccine in preventing a variety of different COVID-19-related outcomes.
In the abstract the researchers reported the vaccine’s effectiveness for several COVID-19-related outcomes at days 14–20 after the first dose and compared those figures to the effectiveness at seven or more days after a second dose was administered.
The push to develop, test, and approve COVID-19 vaccination has focused on adults. But children can, of course, get infected and transmit the disease, even if they are far more likely to experience mild or no symptoms.
The journal Science reported on Tuesday (Feb. 23) that Pfizer and BioNTech have enrolled 2,200 young teens, ages 12-15 in a trial and that Moderna is finishing recruitment of 3,000 study volunteer trial with the same minimum age. The Oxford-AstraZeneca and J&J vaccines are also scheduled to be tested in children and teens, according to the report in Science.