- Medicare will cover at-home COVID tests for beneficiaries. Medicare’s 64 million beneficiaries will be able to get up to eight free at-home COVID-19 tests per month starting early this spring, the Centers for Medicare and Medicaid Services (CMS) announced on Feb. 3. The tests will be available at pharmacies and other stores that participate in the program, which applies both to people with original Medicare and those enrolled in a Medicare Advantage plan. Exact dates of the program’s launch have not been announced. Private insurers are already covering the cost of at-home test kits for their enrollees under new federal guidelines. Until the new Medicare program begins, beneficiaries can still request four free over-the-counter tests delivered to their homes through the federal government website covidtests.gov. COVID-19 tests ordered by health care providers will continue to be covered at no cost for Medicare beneficiaries. CMS has more information on the new program here.
- Pfizer asks FDA to authorize its COVID vaccine series for young kids. Pfizer and BioNTech announced on Feb. 1 that “in response to the urgent public health need” and at the request of the U.S. Food and Drug Administration (FDA), the companies initiated a rolling submission for emergency use authorization (EUA) for its vaccine for kids ages 6 months to 5 years. A complete submission, which includes the first two shots in what is expected to be a three-shot series, is expected in the coming days. In December, Pfizer announced that two shots of a low-dose vaccine did not mount an adequate enough immune response in some kids and that the clinical trials would test a third dose, given at least eight weeks after the second. Data on this third shot is expected in the coming months and will also be submitted to the FDA for review. “If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer’s chairman and CEO Albert Bourla said in a statement. If the FDA authorizes the vaccine, a panel of experts from the Centers for Disease Control and Prevention (CDC) will meet and vote on its use. Coronavirus infections among children have risen sharply during the omicron wave, with more than 3.5 million child cases reported in January, according to the American Academy of Pediatrics. Hospitalizations among children are also at record levels; the highest rates are among kids under 4, who are not yet eligible for vaccination, the CDC reported on Jan. 14.
- Novavax asks for EUA for its vaccine. Novavax has asked the FDA for an EUA for its COVID-19 vaccine. In announcing its request, Novavax officials said its clinical trials showed that the vaccine was safe and provided 90 percent protection against the coronavirus for individuals age 18 and older. These trials were done before the emergence of the omicron variant. The company said the two doses of the vaccine are supposed to be administered 21 days apart and that it is studying the safety and effectiveness of a third dose as well as use for adolescents ages 12 to 17. The Novavax vaccine uses a different technology than the other three vaccines now available to Americans: the mRNA Pfizer-BioNTech and Moderna vaccines, which have been fully approved by the FDA, and the Johnson & Johnson single-dose product, which is available through an EUA. The Novavax vaccine is made using small, laboratory-built pieces of the coronavirus to stimulate immunity, a more traditional approach to a vaccine than the mRNA technology. If the FDA approves the Novavax product, it would then need the go-ahead from the CDC before it could begin to be available to individuals.
- FDA fully approves Moderna vaccine. The FDA on Jan. 31 granted full approval to Moderna’s COVID-19 vaccine, making it the second FDA-approved vaccine for COVID-19 in the U.S., after Pfizer-BioNTech’s product was approved in August. And on Feb. 4, a CDC panel of advisors voted to back the approval and recommended the vaccine for adults 18 and older. The roughly 204 million doses of Moderna’s vaccine that have so far been administered in the U.S. were done so under emergency use authorization. In a statement, Acting FDA Commissioner Janet Woodcock, M.D., said that “for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated” and that the vaccine, which has the brand name Spikevax, “meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States.” About 32 percent of the U.S. population that is eligible for vaccination remains unvaccinated, federal data shows.
- FDA stops use of two monoclonal antibody treatments. The FDA announced on Jan. 24 that people with COVID-19 should no longer receive the monoclonal antibody treatments bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab), which were authorized to treat the disease in high-risk individuals in 2021. The two treatments are not effective against omicron, the new variant that makes up 99 percent of all coronavirus infections in the U.S., according to health officials. “In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions,” the FDA said in a statement. There are a few other therapies available to treat COVID-19, including the monoclonal antibody sotrovimab and two new antiviral pills from Pfizer and Merck. These drugs, however, have been in short supply during the latest surge. Remdesivir is the only FDA approved drug for COVID-19. The antiviral drug can be administered to people hospitalized with COVID-19 and those at risk of being hospitalized.
- Unvaccinated older adults are nearly 50 times more likely to be hospitalized than their boosted peers. In December, unvaccinated adults 65 and older were 52 times more likely to be hospitalized from COVID-19 than their fully vaccinated and boosted peers, new data from the CDC shows. Unvaccinated adults ages 50 to 64 were 46 times more likely to require hospitalization than boosted people in the same age group. Meanwhile, two federal studies released on Jan. 21 show just how crucial the boosters are in the fight against the highly contagious omicron variant. One multi-state analysis of nearly 90,000 hospitalizations found that the mRNA boosters have been about 90 percent effective at preventing COVID-19-related hospitalizations during omicron. (They were about 94-percent effective at preventing hospitalizations during delta’s dominance, according to the research, also from the CDC.) The booster shots also significantly reduced the likelihood of COVID-19-related emergency room and urgent care visits. A second study found that fully vaccinated and boosted individuals had the best protection against infection during delta and the first few weeks of omicron. Still, only 39 percent of Americans eligible for boosters have received one, CDC data shows.
- CDC says Pfizer and Moderna vaccine recipients should boost at five months. People who were vaccinated for COVID-19 with either Pfizer-BioNTech’s product or Moderna’s vaccine should get their third booster shot five months after their second dose, instead of six, the CDC says. Director Rochelle Walensky said in a Jan. 4 statement that the new recommendation ensures that “people are able to get a boost of protection in the face of omicron and increasing cases across the country.” For Johnson & Johnson recipients, the interval between the initial shot and a booster shot is two months. The CDC is also recommending that children ages 5 to 11 who are moderately or severely immunocompromised get a third dose of Pfizer’s product — the only vaccine authorized for this age group — 28 days after their second shot.
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