J&J Seeks Emergency Approval of Single-Dose COVID-19 Vaccine
The world’s first single-dose COVID-19 vaccine, from Johnson & Johnson, has been submitted to the U.S. Food and Drug Administration for emergency use approval.
Preliminary findings from a large international study suggest the vaccine isn’t quite as strong as the two current FDA-approved vaccines from Pfizer and Moderna, which are two-dose vaccines, the Associated Press reported.
However, the J&J vaccine is easier to use and could ease COVID-19 vaccine shortages.
An FDA advisory panel will review data on the new vaccine on Feb. 26. The FDA will then decide whether to approve it.
FDA Vaccine Chief Dr. Peter Marks has cautioned against making comparisons between vaccines before all of the evidence is collected.
“With so much need to get this pandemic under control, I think we can’t ignore any tool in the tool chest,” he told the American Medical Association last week, the AP reported. “We will have to do our best to try to make sure that we find the populations that benefit the most from each of these vaccines and deploy them in a very thoughtful manner.”
The J&J vaccine was 66% effective at preventing moderate to severe COVID-19, and 85% protective against the most serious symptoms, according to early results of the clinical trial that included 44,000 people in the United States, Latin America and South Africa, the AP reported.
And starting 28 days after receiving the vaccine, no one who got it required hospitalization or died.
Lawsuit Launched Over Color Additive Used in Impossible Burgers
Too little testing was done before the U.S. Food and Drug Administration approved a genetically-engineered color additive that makes Impossible Foods’ vegan burgers appear to “bleed” like real meat, the U.S. Center for Food Safety claims.
In court documents filed last week, the nonprofit food advocacy group is challenging the FDA’s 2019 approval of soy leghemoglobin, CBS News reported.
It’s a so-called “heme” colorant that’s produced in genetically engineered yeast and used in Impossible Foods’ plant-based burgers.
“Because [genetically engineered] heme is new to the human diet, and substantial quantities are added to the Impossible Burger, FDA should have required extensive safety testing before approving its use as a color additive, as required by law,” the Center for Food Safety said in a statement.
The FDA approved the substance without long-term animal studies to assess potential risks such as cancer and reproductive harm, according to Bill Freese, the center’s science policy analyst, CBS News reported.
“We find this to be all the more troubling because a number of potential adverse effects were detected in a short-term rat trial: disruption of reproductive cycles and reduced uterine weights in females, and biomarkers of anemia, reduced clotting ability, and kidney problems,” Freese said.
An FDA spokesperson said the agency does not comment on possible, pending or ongoing litigation.
An Impossible Foods spokesperson said that all of its products had “undergone rigorous safety testing and meet or exceed all relevant federal requirements,” CBS News reported.
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Posted: February 2021