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.

FDA panel unanimously recommends emergency use

A key advisory body to the Food and Drug Administration was unanimously supported on Friday Johnson & Johnsonis single shot Coronavirus Emergency vaccine, a crucial step paving the way for a third preventive treatment to be distributed in the US next week.

The non-binding decision, made 22-0 by the FDA’s Advisory Committee on Vaccines and Related Biological Products, comes because the Biden government is working to increase the supply of vaccine doses and get Americans vaccinated as soon as possible. US health officials are increasingly concerned about new emerging variants of the virus, particularly South African strain B.1.351, which has been shown to reduce the effectiveness of vaccines on the market and under development.

The head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, warned earlier Friday that the decreases in Covid-19 cases reported in the US since the beginning of January could flatten as the variants continue to spread.

“In the past few weeks, cases and hospital admissions in the US have decreased since early January, and deaths have decreased over the past week,” Walensky said during a press conference at the White House. “However, the latest data suggests that these declines may stall and possibly weaken if a number is still very high.”

Scaling-up vaccinations could help mitigate the effects of the highly contagious variants, Adam MacNeil, epidemiologist at the CDC, said during a presentation the Friday before the vote. He added that The US “is not close to herd immunity”But vaccinations could help “bring us closer to closing the herd immunity gap”.

The FDA advisory panel plays a key role in approving flu and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not have to follow the advisory board’s recommendation, it often does. For similar inquiries from Pfizer and ModernThe FDA approved these companies’ vaccinations the day after the committee endorsed the emergency use approval. If J&J follows the pattern, a third vaccine could be approved on Saturday.

After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and voting committee member, said J & J’s vaccine will help “meet the needs of the moment” as states complain that there is insufficient supply Pfizer and Moderna gives vaccinations.

“We have to get this vaccine out now,” said Dr. Jay Portnoy, professor at UMKC School of Medicine and voting committee member, after the vote. He added, “We are in a hurry” as the variants pose a threat to the nation’s progress on the pandemic.

Initially the doses would be limited. The U.S. plans to ship 3 to 4 million doses of J & J’s vaccine to states, pharmacies and community health centers next week pending FDA approval, President Joe Biden’s Covid czar Jeff Zients told reporters on Wednesday . The company expects to drop 20 million cans by the end of March. Dr. Richard Nettles, Vice President of Medical Affairs, J&J, said House Legislators on Tuesday. J&J has signed a contract with the US government to deliver 100 million doses of its vaccine by the end of June.

Federal and state health officials have been eagerly awaiting approval of J & J’s vaccine. Unlike Pfizer and Moderna’s vaccines, which require two doses three to four weeks apart, J&J only requires one dose, which makes logistics easier for healthcare providers. J & J’s vaccine, unlike the other two vaccines, which must be stored at subzero temperatures, can also be stored at refrigerator temperatures for months.

J & J’s single-dose vaccine “is easier to use in many contexts,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases of the CDC, told the Journal of the American Medical Association during a question and answer session Friday. “I suspect that much of the national health consideration given to these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited to some populations.”

An EUA means that the FDA allows some people to receive the vaccine while the agency continues to analyze data. This is not the same as a full approval which requires more data and which can typically take several months longer. J&J, like Pfizer and Moderna, has only submitted safety data for two months, but the agency typically takes six months for full approval. The company is asking the FDA to approve use of the vaccine in people 18 years and older.

NOT A WORD submitted his Covid vaccine data J&J said the level of protection the vaccine provided varies by region. The shot shows an overall effectiveness of 66%, 72% in the USA, 66% in Latin America and 57% in South Africa. Variant B.1.351 spreads quickly. However, FDA staff records indicate that the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospital stays and deaths.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

FDA staff approved J & J’s vaccine on WednesdayDocuments state that the clinical trial results and safety data “are in line with recommendations in FDA guidelines on approving the emergency use of vaccines to prevent COVID-19.”

The FDA report found no specific safety concerns for the vaccine when analyzed by age, race, and comorbidity. Were headache, fatigue and muscle pain some of the most common side effects among the people who received the vaccination, the report said. There have also been reports of nausea, fever, and pain at the injection site.

Macaya Douoguih, director of clinical development and medical affairs for the vaccines division at J & J, Janssen, told the FDA panel on Friday that two people had severe allergic reactions shortly after receiving the vaccine. One of the people participated in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.

The FDA report says there have been some cases of Bell’s palsy, a condition in which half of your face falls off but was “balanced” with the number in the general population. The FDA previously announced that the condition would be monitored in vaccine recipients after flagging it as a potential problem with Pfizer’s shots, and noted that this isn’t necessarily a side effect, but it is worth looking out for.

– CNBCs Hannah Miao contributed to this report.