FDA authorizes J&J's one-shot coronavirus vaccine
Saturday, February 27, 2021
Source: BioPharma Dive
The Food and Drug Administration on Saturday gave emergency authorization to a coronavirus vaccine developed by Johnson & Johnson, making a third shot available at a critical moment for U.S. efforts to control COVID-19.
J&J's vaccine, which requires one dose rather than two and can be stored at refrigerator temperatures, will provide much-needed reinforcements as states across the country expand eligibility for immunization beyond older adults and healthcare workers.
Only a few million doses are immediately available to ship, however. Deliveries could begin as soon as early next week, an FDA official said Saturday. J&J expects to deliver 20 million doses by the end of March and 100 million by the end of June, adding to increasing supplies from Pfizer and Moderna, which developed the two other vaccines authorized for use in the U.S.
More than 47 million people in the U.S., or roughly 14% of the population, have received one or more doses of either Pfizer's or Moderna's vaccines, according to federal government data. But the rollout of both has been complicated by their two-dose regimens, which require people to return for a second shot three or four weeks later, and by the freezer temperatures needed for shipping and storage.
J&J's vaccine offers a simpler option, particularly for more rural areas or communities with fewer pharmacies or clinics. Its availability, while initially limited, could help the U.S. keep COVID-19 hospitalizations and deaths from rising again after sharp declines in recent weeks.
The FDA's authorization came one day after a group of independent experts unanimously supported the vaccine's use in adults 18 years and older, judging its benefits easily outweighed its risks in a 22-0 vote.
"We're still in the midst of a deadly pandemic," said Archana Chatterjee, dean of Chicago Medical School at Rosalind Franklin University and a member of the advisory committee, at Friday's meeting. "There is a shortage of vaccines that are currently authorized and I think authorization of this vaccine will help meet the needs of the moment."
The U.S. is the second country to authorize J&J's vaccine following Bahrain, which did so earlier this week. A Centers for Disease Control and Prevention panel will meet Sunday to discuss guidelines for its use in the U.S.
"The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States," said Janet Woodcock, the FDA's acting commissioner, in a statement Saturday.
J&J's vaccine is backed by results from an international study that enrolled about 44,000 participants in the U.S., South Africa, Brazil and five other South American countries. The data showed vaccination was 66% effective in preventing moderate or severe COVID-19 beginning 28 days after volunteers received their shot.
J&J's definition of moderate COVID-19 is close to what other drugmakers have considered symptomatic, and a separate analysis calculated equivalent efficacy against all symptomatic COVID-19.
While the efficacy was lower than the roughly 95% protection demonstrated for Pfizer's and Moderna's vaccines, it's still well above the threshold set by U.S. regulators for authorization. And unlike the other two, J&J tested its shot in countries where a coronavirus variant that can weaken vaccine potency was already spreading.
Protection was greater, at 85%, against severe COVID-19. No participants who received the vaccine were hospitalized with COVID-19 after 28 days, nor did any die from the disease.
The FDA advisers who reviewed the data Thursday agreed the vaccine's efficacy was still convincing.
"It's a relatively easy call," said Eric Rubin, a committee member and editor-in-chief of the New England Journal of Medicine, on Friday. "This clearly gets way over the bar and it's nice to have a single-dose vaccine."
A study testing two doses is currently ongoing and could yield data later this year, potentially presenting a communication challenge should a second shot increase protection.
Clinical testing has shown the vaccine to be safe, with injection site pain, headache and fatigue as the most common side effects. In its review, the FDA noted more cases of hives and blood clots occurred in vaccinated volunteers than those receiving placebo, but the total number of people was very few and determined not to be caused by the vaccine.
There was some concern at Friday's advisory meeting that the vaccine might not work as well in adults over 60 years of age with underlying risk factors for worse disease outcomes. But both the FDA and the committee felt the number of cases among study participants in that category was too small to make a definitive conclusion, noting efficacy improved when more cases were included.
"Obviously we'll watch that as additional data come in," said Peter Marks, head of the FDA division that reviews vaccines, on a Saturday call with reporters. "At this time, there's no concern about reduced efficacy in the older population."
Potentially more worrisome was the comparatively weaker performance of J&J's vaccine against a coronavirus variant first observed in South Africa that's since spread to many other countries, including the U.S. Vaccinated volunteers in the study were still equally protected against severe disease, however, a point emphasized by the FDA.