FDA deems Johnson & Johnson COVID-19 vaccine safe and effective

The U.S. Food and Drug Administration has deemed Johnson & Johnson's COVID-19 vaccine safe and effective in an analysis released Wednesday morning that paves the way for the drugmaker's request for emergency use authorization.

The vaccine will be evaluated by a panel of FDA advisors on Friday who will decide whether the new vaccine meets the criteria. If it does, it would join the Pfizer-BioNTech and Moderna vaccines, which have been approved and are being distributed at sites around the country.

The FDA's review found the Johnson & Johnson vaccine to be 66% effective overall in preventing moderate to severe COVID-19 in test subjects. While that's lower than the 94.1% efficacy rate of the Moderna vaccine, and the 95% rate of the Pfizer-BioNTech iteration, the Johnson & Johnson vaccine does come with the built-in advantages of requiring only one shot and needing no special below-freezing storage.

The agency cited no specific safety concerns for the new vaccine, and said it had a favorable safety profile, with the most common adverse reactions being mild to moderate injection-site pain, headache, fatigue and muscle pain.

One area in which the Johnson & Johnson vaccine will likely fall short is in the initial supply. A company executive said during Congressional testimony on Tuesday that four million doses would be available once the FDA grants emergency use authorization, with a total of 20 million doses ready by the end of March and 100 million doses by the end of June.

That's far short of the production goals cited by the company, which initially pegged the end-of-February supply at 10 million doses, according to CBS News. While the Biden administration expects to be able to send two million doses to select jurisdictions next week, states are still not sure how many doses they should expect.

The Biden administration said Monday that it's waiting to finalize its distribution strategy until after the vaccine receives input from both the FDA and the Centers for Disease Control and Prevention.

THE LARGER TREND

Vaccine supply, which began going out in December, has been short of demand as states announce phases for inoculation. To speed up vaccinations, federal COVID-19 Vaccine Coordinator Jeff Zients announced earlier this month that, starting February 11, a million doses of the vaccine will be shipped directly to 6,500 pharmacies to get shots into arms, following individual state guidelines.

The federal government has been working to speed up the production, distribution and administration of the vaccine, working against spreading coronavirus variants first reported in the U.K. and South Africa.

In October, then Centers for Medicare and Medicaid Administrator Seema Verma made it clear that consumers would have access to a COVID-19 vaccine at no out-of-pocket cost, in an interim final rule released on October 28, 2020.

In late January, America's Health Insurance Plans added a resource page on what insurers are doing in the COVID-19 vaccine effort. The resource page includes actions being taken by individual insurers to provide access and to cover the cost of the vaccine, including deductibles and copays.

It also includes a list of frequently asked questions focused on issues such as coverage, coding and billing, the timing and availability of vaccines, links to government toolkits and legislation focused on the vaccines.

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com