FDA panel unanimously recommends emergency use

A key advisory body to the Food and Drug Administration unanimously endorsed Johnson & Johnson’s emergency single-shot coronavirus vaccine on Friday. This is a critical step that paves 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 on Friday that the decreases in Covid-19 cases reported in the US since early 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 “isn’t getting close” to herd immunity, but vaccination may 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. At a similar request from Pfizer and Moderna, the FDA approved these companies’ vaccinations the day after the committee endorsed approval for emergency use. 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 doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told the House legislature 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.

J&J submitted its Covid vaccine data to the FDA on February 4th. The vaccine’s level of protection varies from region to region, J&J said, with the shot showing an effectiveness of 66% overall, 72% in the US, 66% in Latin America and 57% in South Africa, where variant B.1.351 is spreading rapidly. 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 officials on Wednesday approved J & J’s vaccine and stated in documents that the clinical trial results and safety data “are in line with recommendations in the FDA’s 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. Headache, fatigue, and muscle pain were some of the most common side effects in 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.

CNBC’s Hannah Miao contributed to this report.

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