Biotech ETFs are climbing Wednesday as the Food and Drug Administration’s staff endorsed Johnson & Johnson’s coronavirus vaccine for emergency use, a key step in offering a third vaccination to the U.S. marketplace.
The staff report released Wednesday is a preliminary step designed to prepare the FDA’s Vaccines and Related Biological Products Advisory Committee to make a decision. The group will meet Friday to review J&J’s request for emergency use authorization. Approvals occurred shortly after similar requests by Pfizer and Moderna.
After JNJ submitted its vaccine study data to the Food and Drug Administration earlier this month, the FDA staff said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”
The vaccine’s level of protection varied by region, J&J said, with the shot demonstrating 66% effectiveness overall, 72% in the United States, 66% in Latin America, and 57% in South Africa, where the B.1.351 variant is rapidly spreading. However, the FDA staff documents showed the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospitalizations and deaths.
The news arrives amid efforts by the Biden administration to increase the supply of doses after states complained that demand was outpacing supply, with many Americans unable to get a second shot.
White House Preparing for J&J Rollout
Pfizer’s vaccine was found to be 95% effective against preventing the coronavirus, while Moderna’s was found to be about 94% effective. Infectious disease experts pointed out that while J&J’s numbers are lower, they can’t be used as a direct comparison to the other two vaccines because it’s a single dose and the company’s trial was conducted when there were significantly more infections as well as new, more contagious variants.
The White House is touting its progress in disseminating the vaccine, hoping even more Americans will be vaccinated shortly.
“From 8.6 million doses when we took office to 14.5 million doses this week, that’s an increase of vaccine allocations to states of nearly 70% during the Biden-Harris administration,” White House Covid coordinator Jeff Zients said during a White House news briefing.
“In this week, we will increase the allocation to pharmacies to 2.1 million doses,” Zients said. “So, with 14.5 million doses allocated to states, tribes and territories, and 2.1 million through the federal retail pharmacy program, we’ve nearly doubled weekly supply of doses in just five weeks.”
Zients also said the Biden administration is readying rollout plans for 3-4 million doses of the Johnson & Johnson coronavirus vaccine next week, given that the vaccine is approved for use.
“While we await the FDA decision, we want the American people to know that we’re doing the work so that if the EUA is issued, we will waste no time getting this lifesaving vaccine into the arms of Americans,” Zients said at Wednesday’s virtual Covid briefing.
“If authorized, we are ready to roll out this vaccine without delay,” Zients said, noting that this vaccine’s distribution will mirror the current allocations process across jurisdictions, pharmacies, and community health centers.
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