The Biden Administration is making preparations for the winter coronavirus surge. It outlines how it intends to authorise reformulated shots to boost fall supply and to suspend a program which provided at-home viruses tests for free to preserve supplies.
The Administration cited a shortage of funding from Congress when it decided to suspend COVIDTests.gov delivery as of Friday, and to stockpile testing for later in the year.
“We are therefore suspending all new orders under this program in order to conserve our remaining supplies so we can make sure we have enough tests in the fall, when there might be an increase in infections or more acute needs,” said a top administration official 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. However, the U.S. experienced major transmission spikes around winter holidays in 2020 as well as 2021,. As temperatures drop, health officials will remain vigilant.
Speed is an important factor in the Food and Drug Administration’s plans to approve boosters targeting omicron strains. However, there are no data about how these shots perform in people.
FDA Commissioner Robert M. Califf stated that the procedure is very similar to one used by regulators each year to combat the flu. In which shots are modified to fit circulating strains, the FDA process must also be followed. 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 have seen, it is possible to make strain changes without altering safety .
Drugmakers Moderna and Pfizer BioNTech are asking for authorization to use “bivalent booster shots” that attack both the original coronavirus strain and fast-moving BA.4/BA.5 variants. These are more dominant than the existing immune defenses and are capable of evading them.
Multivalent and bivalent vaccines are common. Modifying a vaccine to contain different strains of virus is not difficult. Dr. Califf explained that Bivalent or multivalent vaccines can be modified without changing other ingredients. The FDA has extensive experience in reviewing strain variations in vaccines. This is what was done for the annual flu vaccine .”.
FDA advisors agreed that fine-tuning shots to target micron and spinoffs before a winter surge was the best strategy. Dr. Califf stated that the FDA doesn’t plan on reconvening the advisory panel because the members of the June session weighed in.
Some people may be dissuaded from receiving the shot because they lack new data from human trials. Persons 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.
A little less than half (or roughly one-third) of Americans who have been fully immunized have chosen to receive an initial booster shot.
Persons 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 has, in the meantime, distributed more 600million tests via COVIDTests.gov.
President Biden initiated the initiative in January, after it was apparent that the administration had failed to ensure adequate supply of testing supplies during the holiday omicron waves. The U.S. The Postal Service delivered free batches of test kits to Americans’ homes.
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 testing will continue to be available for long-term care facilities as well as schools, early learning centers, children-care and child-care centers, food banks, and community health centers. Also, there are 15,000 federally-supported free testing sites in community locales such as pharmacies and libraries.
A senior administration official stated that the U.S.-based web-based program relies on U.S. funding. If Congress approves new funding, the Postal Service can resume.
” Until then, the official stated that “we believe reserving remaining tests for distribution late this year is the best course .”
For more information, visit The Washington Times COVID-19 resource page.