Updated COVID-19 vaccines will be available in mid-September, officials say
COVID-19 vaccines that have been tweaked to teach the body how to fight off the current tide of circulating variants are now expected to hit drugstores and clinics in mid-September, senior government officials say. Officials spoke on Thursday about the U.S. government’s preparations for the fall and winter respiratory virus season on condition that they not be named. The US Food and Drug Administration is expected to approve the updated vaccines in a few weeks. Then the Advisory Committee on Immunization Practices, a group of independent experts that advises the US Centers for Disease Control and Prevention on their vaccination decisions, will consider the safety and effectiveness of the new vaccines and make recommendations for their use. After the CDC director signs off on these recommendations, the vaccines can be administered. Officials said ACIP will meet soon after the FDA’s decision to expedite regulatory moves to get the vaccines to market. The advisory group is scheduled to meet on September 12 to discuss COVID-19 vaccines, meaning the vaccines could be available soon. The announcement comes amid a late summer surge in COVID-19. The CDC tracks the disease through hospitalizations and emergency room visits, as well as sewage monitoring and testing of travelers at some airports. More than 12,600 Americans are hospitalized with COVID-19, and that number is rising, up 22% in the last week. However, officials said these are levels mostly about a third of where they were a year ago thanks to immunity to vaccination and previous infections. But antibodies to COVID-19 wane over time, and many Americans are in need of a boost. Only about 17% of beneficiaries received the bivalent vaccines last fall, when the vaccines were last updated. Three vaccines are expected to be available this year. Two are mRNA vaccines from Pfizer and Moderna and a third is a protein subunit vaccine from Novavax. The Novavax vaccine uses an older type of technology that contains the spike protein from the virus that causes COVID-19 and an ingredient that boosts the immune system to make antibodies against it. Both vaccine technologies are well understood and safe, and have been shown in practice and clinical trials to reduce the risk of hospitalizations and deaths from COVID-19, officials said. The FDA plans to grant full approval for the Pfizer and Moderna vaccines for people ages 12 and older. Vaccines for children under 11, as well as the Novavax vaccine, will be available under an emergency authorization, officials said. Vaccines have been updated to teach the body to fight the XBB.1.5 subvariant of the coronavirus. They are also expected to retain their potency against closely related strains. All three vaccine manufacturers say clinical trials show their vaccines are effective against EG.5, the current dominant strain in the US. While vaccines have previously been made available free of charge by the government, this is the first time vaccines have been made available through the commercial market. Under the Affordable Care Act, most insurance plans must cover the entire cost of vaccinations with no co-payments. Those who are uninsured or under-insured can still get vaccinated for free through a government “This bridging program will exist through multiple channels,” CDC Director Mandy Cohen said in an interview with CNN last week. “People can go to a state-approved health center or to their health department. …And the third option is that we work with pharmacy partners like CVS, Walgreens, Walmart, and others to make it available in pharmacies.” “The details of the pharmacy program are still being worked out and there may be slight delays in procurement free vaccines are coming in some stores. But public health departments and state-qualified health centers should have them immediately, Cohen said. People just had to tell their vaccination provider that they were uninsured to be eligible for the benefit, she said. In addition, there are still significant numbers of the COVID-19 tests in the strategic national stockpile. The government has sent out these free tests to nursing homes and assisted living facilities, government health centers, schools, libraries and a range of other public bodies. That program will continue, officials said. There’s also the possibility of bringing back Covidtest.gov, the website where people can order free tests.
Senior administration officials say COVID-19 vaccines that have been tweaked to teach the body how to fight off the current tide of circulating variants are now expected to hit drugstores and clinics by mid-September.
Officials spoke Thursday about the U.S. government’s preparations for the fall and winter respiratory virus season, on condition that their names not be named.
The U.S. Food and Drug Administration is expected to give its approval on the updated vaccines in a few weeks. Then the Advisory Committee on Immunization Practices, a group of independent experts that advises the US Centers for Disease Control and Prevention on their vaccination decisions, will consider the safety and effectiveness of the new vaccines and make recommendations for their use. After the CDC director approves these recommendations, the vaccines can be administered.
Officials said ACIP will meet soon after the FDA’s decision to expedite regulatory moves to get the vaccines to market. The advisory group is scheduled to meet on September 12 to discuss the COVID-19 vaccines, meaning the vaccines could be available soon.
The announcement comes amid a late summer surge in COVID-19. The CDC tracks the disease through hospitalizations and emergency room visits, as well as sewage monitoring and testing of travelers at some airports. More than 12,600 Americans are hospitalized with COVID-19, and that number is rising, up 22% in the last week.
Still, officials said, those levels are about a third of what they were a year ago, largely due to immunity to vaccination and previous infections.
But antibodies to COVID-19 wane over time, and many Americans are in for a boost. Only about 17% of beneficiaries received the bivalent vaccines last fall, when the vaccines were last updated. Three vaccines are expected to be available this year. Two are mRNA vaccines from Pfizer and Moderna and a third is a protein subunit vaccine from Novavax. The Novavax vaccine uses an older type of technology that contains the spike protein from the virus that causes COVID-19 and an ingredient that boosts the immune system to make antibodies against it.
Both vaccine technologies are well understood and safe, and have been shown in practice and clinical trials to reduce the risk of hospitalizations and deaths from COVID-19, officials said.
The FDA plans to grant full approval for the Pfizer and Moderna vaccines for people ages 12 and older. Vaccines for children under 11, as well as the Novavax vaccine, will be available under an emergency authorization, officials said.
Vaccines have been updated to teach the body to fight the XBB.1.5 subvariant of the coronavirus. They are also expected to retain their potency against closely related strains. All three vaccine manufacturers say clinical trials show their vaccines are effective against EG.5, the current dominant strain in the US
While vaccines have previously been made available free of charge by the government, this is the first time vaccines have been made available through the commercial market. Under the Affordable Care Act, most insurance plans are required to cover the entire cost of vaccinations with no co-payments.
People who are not or not sufficiently insured can still be vaccinated free of charge through a state bridging program.
“This bridge program will exist through a few channels,” CDC Director Mandy Cohen said in an interview with CNN last week. “People can go to a state-approved health center or to their health department. … And the third option is that we work with pharmacy partners like CVS, Walgreens, Walmart and others to make it available in the dispensaries.” as well as.”
The details of the pharmacy program are still being worked out and there may be a slight delay in getting free vaccines at some stores. But public health agencies and federally qualified health centers should have them immediately, Cohen said.
To be eligible for the benefit, people would just have to tell their vaccination provider that they don’t have insurance, she said.
In addition, a significant number of COVID-19 tests remain in the strategic national stockpile. The government has sent out these free tests to nursing homes and assisted living facilities, government health centers, schools, libraries and a range of other public bodies. That program will continue, officials said. There’s also the possibility of bringing back Covidtest.gov, the website where people can order free tests.
