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J&J asks FDA for emergency clearance of coronavirus vaccine

Dive Brief:

  • Johnson & Johnson on Thursday said it has asked the Food and Drug Administration for emergency authorization of its coronavirus vaccine, submitting an application less than one week after announcing a single shot protected volunteers in a large study from developing COVID-19.

 

  • With the application in, the FDA will begin reviewing data from that trial, which showed vaccination was 66% effective in preventing moderate or severe disease. Protection was greater, at 85%, against just severe disease and there were no deaths related to COVID-19 among participants who received the shot.

 

  • The FDA has scheduled a meeting on Feb. 26 for independent advisers to assess the study results, meaning an authorization by the end of the month is possible. The agency cleared vaccines developed by Moderna and partners Pfizer and BioNTech one day after positive recommendations from advisers in two mid-December meetings.

Dive Insight:

If authorized as expected, J&J’s vaccine would greatly bolster an immunization campaign in the U.S. that’s still struggling to work out the many kinks that have slowed the roll-out of Pfizer’s and Moderna’s shots.

While the U.S. government has so far allocated more than 57 million doses, only 35 million have been administered to date. Both Pfizer’s and Moderna’s shots are given via two doses, spaced three or four weeks apart, respectively.

Proven protective as a single dose, J&J’s vaccine is substantially easier to administer, especially so for some of the harder-to-reach groups that are now prioritized for vaccination. The vaccine can also be shipped and stored at refrigerator temperatures, rather than the ultra-cold temperatures Pfizer and Moderna require for their products.

J&J expects to supply 100 million doses to the U.S. by the end of June, although it’s not clear how many the drugmaker will have available upon an authorization from the FDA. A government report from last month indicated about 2 million would be ready.

“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” said Paul Stoffels, J&J’s chief scientific officer, in a Feb. 4 statement.

By setting the advisory committee meeting for Feb. 26, the FDA appears to be following a pattern set with its reviews of Pfizer’s and Moderna’s vaccines. In each case, the agency scheduled a panel meeting about three weeks after the companies submitted their applications.

The advisers review both the companies’ presentations and separate assessments compiled by FDA scientists and then vote on questions put to them by the agency. Their recommendations aren’t binding, but the FDA usually follows their advice.

In the intervening time, FDA staff pore over data submitted by the developers, running their own analysis and testing whether the company’s conclusions were accurate and unbiased. They also review the companies’ production plans and processes for avoiding contamination.

The large trial J&J used to test its vaccine’s effectiveness enrolled 43,000 participants from the U.S., South Africa and six other countries. In the U.S., efficacy was estimated at 72%. But in South Africa, where a coronavirus variant was first detected and quickly spread, vaccination was only 57% effective, a worrisome sign of weaker potency against certain mutations.

J&J’s estimate of protection against severe disease was calculated across all studies in the trial, and the company noted protection increased over time.

The U.S. funded more than half of the study’s costs through Operation Warp Speed, the vaccine program set up by the Trump administration. In addition to funding development, the federal government also paid $1 billion for the 100 million doses that it preordered.

Novavax, another vaccine developer backed by Operation Warp Speed, said Thursday it had begun a “rolling review” process with regulators in the U.S., U.K., EU and Canada. Results from studies in the U.K. and South Africa showed the shot was strongly effective at preventing COVID-19, the company said last week, although protection among volunteers in South Africa was similarly lower than elsewhere.