Not surprisingly, the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously today to recommend emergency use approval of Johnson & Johnson’s (Janssen subsidiary) COVID-19 vaccine in people 18 and older. The FDA’s internal review recommended approval several days ago, as noted in a prior blog. The committee found no reason to disagree. Full approval by the FDA and CDC should happen within days.
The vaccine is the third authorized for use in the United States. It is, however, the first one-dose vaccine and can be stored in refrigerators rather than complex freezers. This will facilitate distribution, especially to rural areas.
The vaccine was tested in late-stage clinical trials in more than 44,000 people in the US, South Africa and Latin America. As previously stated, although the US efficacy against being infected with COVID-19 was 72% and it was more effective (85%) in preventing severe disease and no one who got the vaccine died of Covid-19 during the trial. There were two apparent allergic reactions to the vaccine, making it similar or slightly more likely to cause this reaction than the RNA vaccines from Moderna and Pfizer.
I still believe this will become a more effective, two dose vaccine when supply is more in line with demand.
In another important development today, Pfizer was authorized by the FDA to store its COVID vaccine at normal freezer temperatures. This decision is hoped to improve distribution of the vaccine for rural sites and decrease the possibility of wastage due to a problem with storage.
Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage,” FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks said. “This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions.” Previously, the Pfizer vaccine had to be stored at subzero temperatures.
Together, this means more vaccine, in more places and more hope to end the pandemic!