The Biden administration is taking steps to prepare for a possible winter surge of the coronavirus, detailing how it plans to authorize reformulated shots for a fall booster campaign and suspending a program that provided free at-home virus tests to conserve supply.
The administration pointed to a lack of new funding from Congress in choosing to suspend delivery through COVIDTests.gov as of Friday and stockpile tests for later this year.
“As a result, we are suspending new orders through this program to preserve our limited remaining supply, so that we can ensure we have a limited supply of tests available in the fall when we might face a new rise in infections and more acute need,” a senior administration official said Monday.
Reported daily cases in the U.S. have dipped below 90,000 per day and hospitalizations recently sank below 40,000 for the first time since mid-July. The U.S. saw major spikes in transmission around the winter holidays in 2020 and 2021, however, so health officials will be on-guard as temperatures cool.
Speed is a factor as the Food and Drug Administration plans to authorize boosters that target omicron strains this fall without full data on how the reformulated shots performed in humans.
FDA Commissioner Dr. Robert M. Califf said the process is similar to the one regulators use each year for the flu, in which shots must be modified to match circulating strains. He said regulators will rely on real-world evidence from existing COVID-19 shots delivered to millions of people, clinical trial data on shots that targeted different omicron subvariants, and non-clinical data from the lab on the BA.4/5 shots that will be rolled out by September or October.
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“Real-world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” Dr. Califf tweeted. “As we know from prior experience, strain changes can be made without affecting safety.”
Drugmakers Pfizer-BioNTech and Moderna are seeking authorization for “bivalent” booster shots that target both the original strain of the coronavirus and the fast-moving BA.4 and BA.5 variants that are dominant and can evade existing immune defenses to a degree.
“Bivalent and multivalent vaccines are very common, and modifying a vaccine to include different virus strains often does not require a change in other ingredients,” Dr. Califf wrote. “FDA has extensive experience with reviewing strain changes in vaccines, as is done with the annual flu vaccine.”
FDA advisers agreed in June that fine-tuning the shots to target omicron and its spinoffs was the best approach ahead of a possible winter surge. Dr. Califf said the FDA does not plan to reconvene the panel of advisers because they weighed in during the June session.
The lack of new human-trial data could dissuade some people from getting the shots. People who’ve resisted COVID-19 shots have cited the size of the trials or the fact that messenger-RNA technology used in the shots is relatively new.
Slightly less than half of those fully vaccinated — or roughly a third of the U.S. population — have opted to get an initial booster shot.
Individuals older than 50 have been eligible for a second booster since earlier this year, though only a third of people in that age group have come forward for one.
The home-testing program, meanwhile, has distributed over 600 million tests through COVIDTests.gov.
President Biden launched the initiative in January after the administration appeared to be caught flat-footed in ensuring adequate testing supply amid the omicron wave that hit over the holidays. Under the program, U.S. Postal Service shipped batches of tests to Americans’ doorsteps at no cost.
Every household had the opportunity to order a total of 16 tests prior to the scheduled pause.
“Ordering through this program will be suspended on Friday, September 2 because Congress hasn’t provided additional funding to replenish the nation’s stockpile of tests,” it says on the program’s website, https://www.covid.gov/tests.
The administration said persons who buy at-home tests in stores will still be eligible for reimbursement by private health insurance, Medicare and Medicaid — types of coverage that reach about 92% of Americans.
Free tests will still be distributed to long-term care facilities, schools, child-care and early-learning centers, community health centers and food banks. Also, there are 15,000 federally-supported free testing sites in community locales such as pharmacies and libraries.
A senior administration official said the web-based program that relies on the U.S. Postal Service will resume if Congress provides new funding.
“Until then,” the official said, “we believe reserving the remaining tests for distribution later this year is the best course.”