The signoff on Friday by CDC Director Rochelle Valensky will mark a significant expansion of the US booster campaign that health officials hope will clear up confusion and give people more protection ahead of holiday celebrations and new daily Covid-19 cases again. have started growing.
“Booster shots have demonstrated the ability to safely enhance people’s protection against infection and dire consequences and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays.” Doctor. Valensky said.
Their decision comes after the Food and Drug Administration authorized additional Pfizer-BioNTech and Moderna supplements for all adults earlier in the day, and health experts advising the CDC voted 11-0 to recommend them.
The advisory panel said the vaccines should be available to all adults and voted unanimously that everyone over the age of 50 should receive them.
Health officials have encouraged additional doses to bolster people’s immune defenses against the virus.
Supplies should be readily available, according to federal and state health officials. The US has purchased a total of 600 million Pfizer-BioNtech doses and 500 million modern doses.
Adults receiving the Johnson & Johnson vaccine are already eligible for the Pfizer-BioNtech and Moderna boosters.
The FDA regulates whether a vaccine works safely enough to be used for external testing. Many doctors, pharmacies and other vaccination sites follow CDC’s direction, which guides the practice of medicine and public health.
The latest moves would essentially make an additional dose now a standard part of COVID-19 vaccination, although some people in the US found ways to get boosters even though they weren’t eligible and some states widened eligibility .
Federal health officials are rapidly expanding access to boosters — and for many, confusing — a series of moves aimed at boosting people’s immune defenses to help America stay ahead of the pandemic.
The Biden administration aimed to make the booster widely available in September. Yet its own health agencies have moved more deliberately, clearing boosters for people with weakened immune systems and then high-risk adults with evidence in support of the move.
One pushing factor is that making boosters available to all adults would eliminate confusion about who should get the dose.
Peter Marks said, “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help eliminate confusion about who can receive a booster dose and ensure that Make a booster dose available to everyone who may need it.” Director of the FDA Center that oversees vaccines.
The latest authorizations apply to adults for at least six months before their second shot, whether they initially received the Pfizer-BioEntech or Moderna vaccine.
The booster expansion comes after a reduction in delta-driven growth over the summer in most states. Some places have recently experienced a surge in cases, leading to an increase in the average number of daily cases nationally. This has increased the chances of getting cold.
Behind the push for boosters is some research finding that vaccination reduces protection against symptomatic infections after six months or so.
Eric Topol, director of the Scripps Research Translational Institute in La Jolla, California, pointed to data from Israel and other recent studies indicating that the booster reduced the risk of hospitalization and death in people who were at least 40 years old. and symptomatic infections in young people.
“This booster has a big bang to stop infection, and that’s the whole point, how do you break the transmission chain,” he said.
Still other health experts say increasing primary vaccination, not boosters, is the best way to protect everyone and reduce the spread of the virus, as studies show that community transmission is mostly driven by non-vaccinated people. it happens.
Critics say the vaccines were not designed to prevent infection, but to prevent serious illness and hospitalization.
“I think the goal should be to reduce serious illness, hospitalization and death. We haven’t achieved that yet and we need to focus on that,” said Celine Gounder, an infectious disease specialist at Bellevue Hospital Center in New York. he said.
She said the available data supports promotion to people over the age of 65 and immunocompromised, but not to the wider population.
Despite the debate, many people have sought booster shots, including those who may not fit the criteria outlined by health officials.
A handful of states and cities, including Arkansas, West Virginia and New York City, have also expanded booster eligibility beyond federal government guidelines in an effort to stem the winter boom.
According to the CDC, since the FDA began authorizing the booster, more than 32 million people have received additional doses, including more than 19 million receiving Pfizer-BioEntech and more than 13 million receiving Moderna. Huh.
The booster expansion simplifies currently confusing recommendations, said Gregory Poland, director of the Mayo Clinic’s vaccine research group. “It makes for a very simple, clear public-health message: If you’re 18 or older, get a booster,” he said.
The CDC’s advisory panel, called the Advisory Committee on Immunization Practices, is a group of medical and public-health experts that makes recommendations to the agency about how vaccines should be used in the US.
In presentations to the panel, Pfizer and Moderna officials said side effects after the booster dose are similar to those reported after the previous dose.
CDC vaccine expert Tom Shimabukuro, presenting data from a federal safety database, said that people who received the third dose of Pfizer-BioEntech or Moderna Vaccines reported fewer side effects than after the second dose.
The data also indicated that those boosted with Moderna reported more side effects than those boosted with Pfizer, regardless of their first vaccines.
According to Cape Talbot, a CDC panel member and associate professor of medicine at Vanderbilt University, the risk of myocarditis after taking a Pfizer-BioNTech booster dose appears to be lower than after the second dose of the vaccine. There is limited data available to assess the risk of myocarditis following a modern booster dose, he said.
Some US safety databases show an increased risk of myocarditis in young men receiving Moderna Vaccine compared to the Pfizer-BioNTech vaccine. The FDA has delayed approving the shot for teens while it investigates whether there is an increased risk of myocarditis. The Moderna booster dose is half the dose of the first two shots.
Sarah Oliver, another CDC official who presented the panel, said Israel has limited data to suggest that booster doses can help reduce community transmission. While the effect may not be permanent, she said a temporary reduction in the holiday and winter season would also be beneficial.
In September, the FDA approved a third dose of the Pfizer-BioEntech vaccine for adults 65 years of age and older or at high risk of serious illness and death, including because of their jobs or where they live.
The government has also supported additional shots of Moderna for people at high risk, and is supporting mixing and matching additional doses of the three vaccines approved for use.
In August, Pfizer and BioNTech sought approval of a booster for people 16 years and older, but the agency limited additional doses to the elderly and adults who were at high risk following outside scientific advisories, they said. They were not convinced that widespread boosters were necessary at the time.
Since then, however, Pfizer and BioNTech shared the results of a study of nearly 10,000 subjects aged 16 years and older, which found that the booster shot was 95.6% effective in preventing symptomatic COVID-19.
The researchers also found that the additional doses were safe and tolerable, and in line with what was known about the vaccine, the companies said.
Last month, the FDA approved Moderna’s booster shot at half the dose of each of the first two shots. Moderna sought authorization for seniors and high-risk adults after Pfizer-BioNtech’s boosters were approved for those people.
In Moderna’s booster application, the company presented data from a study of nearly 300 people, indicating a half-dose booster, given at least six months after the initial vaccination, restored antibody levels.
This story has been published without modification to the text from a wire agency feed
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