Covid-According to CDC and FDA officials, 19 vaccines that have been tweaked to teach the body how to fight the current crop of circulating variants are now expected to hit drugstores and clinics in mid-September.
The officials spoke on condition of anonymity about the US government’s preparations for the fall and winter respiratory virus seasons on Thursday.
The updated vaccines are expected to be approved by the US Food and Drug Administration in the coming weeks. The Advisory Committee on Immunization Practices, a group of independent experts who advise the US Centers for Disease Control and Prevention on vaccination decisions, will then assess the new shots’ safety and effectiveness and make recommendations for their use. Vaccines can be administered after the CDC director approves the recommendations.
Officials stated that ACIP will convene soon after the FDA decision in order to expedite the regulatory process and bring the vaccines to market. The advisory group is scheduled to meet on September 12 to discuss Covid-19 vaccines, implying that the vaccines could be available soon after.
The announcement coincides with a late-summer surge in Covid-19. The disease is being tracked by the CDC through hospitalizations and emergency room visits, as well as wastewater monitoring and testing of passengers at some airports. More than 12,600 Americans have been hospitalized with Covid-19, and the number is growing, increasing 22% in the last week.
Still, officials said, those are about one-third of what they were a year ago, owing largely to immunity from vaccinations and prior infections.
However, antibodies to Covid-19 wane over time, and many Americans are due for a checkup. Only about 17% of those eligible received the bivalent vaccines last fall, when the immunizations were last updated. This year, three vaccines are expected to be available. Pfizer and Moderna have mRNA vaccines, and Novavax has a protein subunit vaccine. The Novavax vaccine employs an older technology that includes the spike protein of the virus that causes Covid-19, as well as an ingredient that stimulates the immune system to produce antibodies against it.
According to the officials, both vaccine technologies are well-understood and safe, and they have been proven in the real world and in clinical studies to reduce the risk of hospitalization and death from Covid-19.
The FDA intends to grant full licensure to Pfizer and Moderna vaccines for people aged 12 and up. Vaccines for children aged 11 and under, as well as the Novavax vaccine, will be made available through an emergency use authorization, according to officials.
The vaccines have been updated to teach the body how to fight the coronavirus subvariant XBB.1.5. They should also retain their potency against closely related strains. All three vaccine manufacturers claim that their vaccines are effective against EG.5, the current dominant strain in the United States.
Previously, vaccines were provided free of charge by the government; however, this is the first time vaccines will be provided through the commercial market. Most insurance plans are required by the Affordable Care Act to cover the full cost of vaccines, with no co-pays.
People without insurance or with insufficient insurance can still get vaccines for free through a government bridge program.
“That bridge program will exist through a few channels,” CDC Director Dr. Mandy Cohen said last week in an interview with CNN. “People can go to a federally qualified health center or to their local public health department.” The third option is that we are collaborating with pharmacy partners like CVS, Walgreens, Walmart, and others to make it available in pharmacies as well.”
The pharmacy program’s details are still being worked out, and there may be a slight lag in receiving free vaccines at some stores. Cohen, however, believes that health departments and federally qualified health centers should have them immediately.
To qualify for the benefit, people will only need to inform their vaccine provider that they do not have insurance, she said.
Furthermore, a significant number of Covid-19 tests remain in the Strategic National Stockpile. The government has been distributing free tests to nursing homes and assisted living facilities, federally qualified health centers, schools, libraries, and a variety of other public-service locations. Officials have stated that the program will continue. There’s also the possibility of resurrecting Covidtest.gov, the website where people can order free tests.