FDA panel unanimously recommends Moderna Covid booster pictures for at-risk adults

A key advisory committee to the Food and Drug Administration unanimously recommended Thursday that booster shots be taken from ModernCovid-19 vaccine for people 65 and older and other Americans at risk. The vote was a critical step before the US can begin giving third vaccinations to some of the more than 69 million people who originally received this vaccine.

The non-binding decision of the Advisory Committee on Vaccines and Allied Biological Products of the FDA would extend the guidelines for Moderna with the third recordings of the FDA PfizerBioNTech Vaccination. These recordings were authorized less than a month ago to a wide range of Americans, including the elderly, adults with pre-existing medical conditions, and those who work or live in high-risk environments such as healthcare and grocery stores.

Although the agency has not always followed the advice of its committee, it often does. A final FDA decision on Moderna boosters could be made within days. A CDC Vaccines Advisory Committee is then expected to vote on the FDA’s proposal next week. If it recommends approval and the CDC endorses it, eligible Americans who completed their vaccinations at least six months ago could begin booster vaccinations immediately.

Booster vaccination has been a controversial issue for scientists – inside and outside of government – especially since many people in the US and other parts of the world have not yet received a single dose of a vaccine. The World Health Organization is urging wealthy countries to wait before distributing boosters, and some scientists say they are not convinced that most Americans need boosters right now.

When the FDA committee met last month, they opposed a proposal to distribute booster vaccines from Pfizer and BioNTech to the general public. Some committee members said at the time they were concerned that there wasn’t enough data to make a recommendation, while others argued that third shots should be restricted to specific groups.

After Moderna’s unanimous vote on Thursday, committee member Dr. Patrick Moore said the data the company submitted for approval of a booster was “not well explained,” adding that he was more on “gut instinct”.

“The data itself is not strong, but it is certainly going in a direction that supports this vote,” he said.

Some members said the boosters should prevent what they call breakthrough infections, which they believe are critical to protecting healthcare facilities from being overloaded, while other members said the third vaccinations should ensure high-risk patients don’t have serious illnesses. Some committee members also suggested that young people might not need boosters as the first few shots in these groups still persist.

Dr. Another member, Paul Offit, stressed that most people who received the first two doses of Moderna’s vaccine are still well protected and hopes the recommendation doesn’t send the “wrong message” to the public.

“If we’re trying to prevent the inevitable, which is a decline in neutralizing antibodies and an erosion of protection against mild or asymptomatic infections, that’s a high bar that we don’t hold any other vaccine by,” he told his colleagues.

The Biden government hopes the extra dose will provide long-term and permanent protection for the US population from serious illness, hospitalization, and death as the fast-paced Delta variant continues to spread.

Dr. Peter Marks, the FDA’s chief vaccine regulator, reached the committee Thursday before the vote, telling the panel of experts that the agency is promoting “all the different viewpoints” on the “complex and evolving” data.

“However, I would ask you, as we move forward, to do our best to focus our reflections on the science related to the proposal under consideration today and not on operational issues related to a booster campaign or related issues global vaccine justice. ”he added.

Moderna filed for FDA approval of a booster dose on September 1. The company said the results are based on a clinical study of about 170 adults, fewer than the 318 people screened for Pfizer’s booster vaccination. Moderna said a third half-dose shot – 50 micrograms – was safe for the first two injections and produced a strong immune response.

Once approved, the company plans to send a letter to health care providers explaining the dose difference for the third injection, said Dr. Jacqueline Miller, the company’s director of infection research, during a presentation Thursday.

The side effects of Moderna boosters were similar to those after the second dose, the company wrote in a document released Tuesday by the FDA. Most of the side effects were of minor severity and Moderna reported no cases of rare heart inflammation, myocarditis, or pericarditis in subjects for up to 29 days after receiving the booster.

Before recommending the third shots, the panel listened to several presentations, including from Israeli health officials, who began to offer boosters to their populations before many other countries. The country has mainly used Pfizer’s vaccine, but some Moderna boosters have been given.

Israel has given 3.7 million third vaccinations since its booster campaign began in late July, with about a third of the extra vaccinations going to people aged 60 and over, Sharon Alroy Price, director of public health at Israel’s Ministry of Health, told the panel.

She presented data suggesting that people receiving a booster dose are less likely to get infected with Covid or become seriously ill. She said officials have so far identified 17 cases of myocarditis or pericarditis after third doses.

“I think we can say, if we look at all of the data in Israel so far, that the use of booster doses has helped Israel reduce the infections and the severe cases,” she said.

– CNBC’s Robert Towey contributed to this report.

CDC endorses third Pfizer doses for high-risk adults

The Centers for Disease Control and Prevention did on Friday the distribution of Pfizer and BioNTech‘s Covid-19 booster vaccinations for older Americans and other vulnerable people, including those in high-risk professional and institutional settings.

Millions of Americans at the highest risk of Covid can now get a Pfizer BioNTech booster shot to increase their protection.

The Agency’s Advisory Committee on Vaccination Practices had previously unanimously endorsed Pfizer’s third vaccination for people 65 years and over and residents of nursing homes and made further recommendations.

CDC director Dr. However, Rochelle Walensky made a recommendation that the advisory panel rejected. The panel voted against giving a booster vaccination to those ages 18 to 64 who were at higher risk of exposure to the virus because of their work place or institutional setting, but Walensky reintroduced that recommendation.

Here’s what the CDC recommends:

  • Individuals 65 years of age and older and residents in long-term care facilities should receive a booster of Pfizer-BioNTech’s Covid vaccine at least 6 months after their Pfizer BioNTech Primary Series;
  • People between the ages of 50 and 64 with pre-existing conditions should receive a booster vaccination from Pfizer-BioNTech at least 6 months after their Pfizer BioNTech primary series;
  • Individuals aged 18 to 49 with underlying conditions may receive a booster dose of Pfizer BioNTech vaccine for at least 6 months after their Pfizer BioNTech Primary Series, depending on individual benefit and risk;
  • Individuals aged 18 to 64 who are at increased risk of exposure and transmission of Covid-19 due to their professional or institutional environment can, depending on the individual, receive a booster dose of the vaccine for at least 6 months after their Pfizer BioNTech primary vaccination course Pfizer-BioNTech receive benefits and risks.

“I believe that we can best meet the country’s public health needs by providing booster doses to the elderly, those in long-term care facilities, those with underlying medical conditions, and adults at high risk of illness from occupational and institutional exposure to COVID. 19, “said Dr. Walensky.

The move is in line with FDA booster approval, she added.

Earlier Thursday, the CDC advisory panel battled a controversial proposal to boost large swaths of the US population and rejected the plan by 9-6 votes. It would have distributed the shots to nursing home staff, people who live or work in prisons and homeless shelters, frontline health workers, unpaid caregivers, and other key workers like teachers.

“I mean, we might as well say give it to anyone over the age of 18,” said committee member Dr. Pablo Sanchez before voting against the proposal.

Lisa Wilson receives a syringe of the Pfizer vaccine at a mobile COVID-19 vaccination center in Orlando, Florida.

Paul Hennessy | SOPA pictures | LightRakete | Getty Images

Dr. Leana Wen, emergency doctor and former Baltimore health commissioner, called the CDC panel’s vote to reject boosters more generally a “mistake” on Twitter.

“Really, are we not allowing health workers, many of whom were vaccinated back in December, to be boostered? What about teachers in cramped classrooms that don’t require masks? ”She tweeted, adding that CDC Director Dr. Walensky should override the recommendation.

The recommendation goes nowhere near as far as President Joe Biden sought. His government said it plans to give booster shots to people aged 16 and over this week. While the CDC panel’s recommendation doesn’t give the Biden administration everything it wanted, boosters will still be around for millions of Americans who originally received Pfizer’s shots.

Confirmation comes a day after the Food and Drug Administration issued emergency use authorization give many Americans third Pfizer shots six months after completing the first two doses. While the CDC committee’s recommendation is non-binding, Walensky is expected to accept the committee’s approval shortly.

Walensky addressed the committee on Thursday ahead of the vote, thanking them for their work and setting out what is at stake.

“These dates are not perfect, but together they paint a picture for us, and they are what we have right now to make a decision about the next phase of this pandemic,” she said.

Before the vote, some committee members expressed concern that the wide range of boosters on offer could affect efforts to get unvaccinated vaccines or reduce confidence in the vaccines’ effectiveness. Others were frustrated that only Pfizer recipients were eligible for the syringes, leaving millions of Americans out of the picture for receiving the Modern and Johnson & Johnson Vaccinations.

The vote came at the end of a two-day meeting during which CDC advisors listened to several presentations of data to support the widespread adoption of booster vaccinations, including one from a Pfizer executive showing data showing a third Injection appears to be safe and increases antibody levels in recipients.

During a presentation on Thursday, CDC officer Dr. Sara Oliver observational studies from Israel in which officials in front of many other countries began vaccinating the country’s population and offering third vaccinations to their citizens in late July.

The Israeli data has been criticized by at least one FDA official for being based on so-called observational studies, which do not meet the same standards as formal clinical studies.

“We can use Israel’s experience to reinforce our knowledge of booster safety,” Oliver said, adding that the country reported only one case of a rare heart infection known as myocarditis out of nearly 3 million third doses administered .

CDC officer Dr. Kathleen Dooling said the data also suggest a third dose may reduce the risk of serious illness in older adults and people with comorbidities. Possible risks include myocarditis, although this risk is very rare and mostly occurs in men under 30, she said.

“The third dose of the Pfizer-BioNTech Covid-19 vaccine appears to have a similar reactogenicity as the second dose,” she added.

The issue of who and when to get boosters has been a controversial issue in the scientific community since the Biden government outlined its plan last month to distribute them widely.

In published a paper Days before an FDA advisory session last week, a leading group of scientists said the available data showed that vaccine protection against serious illnesses persists even as efficacy against mild illness wears off over time. The authors, including two senior FDA officials and several World Health Organization scientists, claimed in the medical journal The Lancet that widespread use of booster syringes to the general public is currently inappropriate.

In the outlines of the plans for last month’s launch Distribute boosters this week, Biden administration officials cited three CDC studies showing that vaccine protection against Covid has waned over several months. Senior health officials said at the time they feared protection from serious illnesses, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.

– CNBC’s Robert Towey contributed to this report.

We will vaccinate our means out of this epidemic if all adults get photographs, says physician

Daylight saving time in the United States could return to pre-Covid-19 normal if 75% to 80% of the US population are vaccinated, said Dr. Peter Hotez on Friday.

“We can vaccinate out of this epidemic if all adults and adolescents are vaccinated by summer. We can have an exceptional quality of life by returning to concerts and music events, as well as ball games, bars, restaurants, clubs and clubs.” all the things we like to do so we have to work towards them, “said Hotez.

Hotez, co-director of the vaccine development center at Texas Children’s Hospital, told CNBC’s “The News with Shepard Smith” However, this vaccine hesitation will prevent the US from vaccinating 75% to 80% of the population.

The demand for the Covid-19 vaccine has dropped across states. Louisiana, for example, asked for fewer cans because the demand was so low. Polls show that more than 40% of Republicans have no plans to get vaccinated, and Hotez advised health professionals to reach out to conservative groups to help protect the entire US population.

“About 40% to 45% of Republicans say they may not or may not take the vaccine, and when you add the numbers that’s about 10% of the adult population,” Hotez said. “There we have to work harder to reach conservative groups … that we have to fix.”

NY expands Covid vaccine eligibility to all adults beginning April 6, Cuomo says

New York Governor Andrew Cuomo will receive a Covid-19 vaccine at a church in Harlem, New York on March 17, 2021.

Seth Little | AFP | Getty Images

New York will expand its Covid vaccine eligibility to all over 30s starting Tuesday, followed by all residents 16 and over on April 6, Governor Andrew Cuomo announced on Monday.

President Joe Biden is moving almost a month before May 1, which is when states can largely open their supplies to all residents.

“Today we are taking a monumental step forward in the fight against COVID,” Cuomo said in a statement. “As we continue to upgrade eligibility, New York will make the vaccine available to every community to ensure justice, especially for color communities too often left behind.”

Nearly 30% of all New Yorkers have been reported to have received at least one vaccine. The state has fired 9,056,970 shots so far.

U.S. tops 100 million Covid vaccine doses administered, 13% of adults now absolutely vaccinated

Residents wait in line to be vaccinated on March 10, 2021 in Chicago, Illinois at a COVID-19 mass vaccination center set up in a parking lot outside the United Center, home of the Chicago Bulls and Blackhawks.

Scott Olson | Getty Images

The U.S. exceeded 100 million Covid-19 vaccine doses administered on Friday, according to the Centers for Disease Control and Prevention.

According to the CDC, more than 35 million people have been fully vaccinated, which is 13.5% of the adult US population. About 65.9 million people have received at least one intake of two-dose therapy, the CDC said.

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