About 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine have been lost after a mix-up at a Baltimore manufacturing plant, the New York Times reported.
The plant, run by Emergent BioSolutions, is tasked with manufacturing two COVID-19 vaccines, the Times reported. Workers at the plant conflated ingredients of the vaccines, ruining the doses, the newspaper reported.
Politico also reported senior officials told them that some senior Biden administration health officials knew two weeks ago that the Baltimore contractor’s production problems could delay delivery of a significant number of future vaccine doses.
The mix-up does not affect Johnson & Johnson doses currently being delivered and used nationwide, since those were developed in the Netherlands, according to the Times.
Johnson & Johnson identified the spoiled batch of doses through its quality control process, the company said in a statement on its website. The site is “not yet authorized to manufacture drug substance for our COVID-19 vaccine,” and added: “This batch was never advanced to the filling and finishing stages of our manufacturing process.”
In its statement, Johnson & Johnson said it remained on track to deliver “an additional 24 million single-shot vaccine doses through April.” The drugmaker didn’t say how many doses were lost.
Also in the news:
►Most Americans 65 and older are fully vaccinated, according to data from the Centers of Disease Control and Prevention.
►California Gov. Gavin Newsom will get vaccinated in Los Angeles Thursday morning, according to his office.
►People Magazine reported Wednesday that former Alaska Gov. Sarah Palin says she tested positive for the coronavirus and is urging people to guard themselves in the pandemic, such as wearing masks in public.
►Washington state is opening eligibility for coronavirus vaccinations to all residents age 16 and older starting April 15.
📈 Today’s numbers: The U.S. has over 30.45 million confirmed coronavirus cases and more than 552,000 deaths, according to Johns Hopkins University data. The global totals: 128.79 million cases and 2.81 million deaths. More than 195.58 million vaccine doses have been distributed in the U.S. and 150.2 million have been administered, according to the CDC.
📘 What we’re reading: COVID-19 accounted for about 11% of all American deaths last year – right behind heart disease and cancer – and the vast majority of patients who died of the virus already had health problems before they were infected.
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FDA authorizes two rapid COVID-19 tests for home screening
Consumers will soon be able to buy rapid COVID-19 tests at chain pharmacies and grocers without a prescription after the Food and Drug Administration on Wednesday authorized two home tests.
The Abbott BinaxNOW COVID-19 self-test will include two tests per kit for serial screening, with the no-prescription test delivering results in 15 minutes that does not require a lab. The FDA also authorized the Quidel QuickVue COVID test that delivers results in 10 minutes and can be used without a prescription.
The FDA has authorized more than 300 COVID-19 tests and technologies in what’s becoming an increasingly crowded field of medical labs and tech firms touting different technologies.
By greenlighting the Abbott and Quidel tests that can be purchased by consumers without a prescription, the federal agency is significantly expanding access to testing for Americans. The authorization comes two weeks after the agency announced a streamlined path for serial testing to screen people without symptoms.
– Ken Alltucker
Pfizer-BioNTech COVID-19 vaccine proves safe and effective for kids ages 12 to 15, company study shows
The COVID-19 vaccine from drug company Pfizer and its German partner BioNTech is safe for and extremely effective in adolescents, according to a company-sponsored study released early Wednesday.
In adolescents 12 to 15 years old, vaccination led to a higher protective antibody response than in adults and was 100% effective against symptomatic disease, the study of 2,260 adolescents found.
The two-shot Pfizer-BioNTech vaccine had been authorized for use in those 16 and up based on previous trials, but not in younger adolescents.
Last week, the companies began testing their vaccine in children ages 5 to 11; next week, they will begin testing in ages 2 to 5, and later they will look at children 6 months to 2 years. Results from those trials should be available later this year.
Moderna, which also has a COVID-19 vaccine, has been studying its shot in teenagers since December and launched a trial in younger children in mid-March. That vaccine is not yet approved for use in older teens.
Pfizer and BioNTech plan to submit their adolescent data to the U.S. Food and Drug Administration to ask that authorization to provide BNT162b2 be quickly amended to include that age group. It’s not clear how long the FDA will take to review the request.
– Karen Weintraub
Contributing: The Associated Press