A key Food and Drug Administration advisory panel on Friday unanimously backed Johnson & Johnson’s coronavirus vaccine for emergency use, a critical step paving the way for distribution of a third preventative treatment in the US next week.
The non-binding decision, passed 22-0 by the FDA’s Vaccines and Related Biological Products Advisory Committee, comes as the Biden administration works to ramp up 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 the B.1.351 strain from South Africa, which has been shown to improve the effectiveness of the vaccines both on the market and in development. decreases.
The head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, warned earlier Friday that declines in Covid-19 cases reported in the US since early January are now leveling off as variants continue to spread.
“In recent weeks, cases and hospital admissions in the United States have been declining since early January and the number of deaths has declined in the past week,” Walensky said during a White House newsletter. “But the latest data suggests these declines may come to a halt, and may be leveling off at a still very high number.”
Scaling up vaccinations could help mitigate the impact of the highly contagious variants, Adam MacNeil, an epidemiologist at the CDC, said in a presentation Friday before the vote. He added that the US is “nowhere near” to herd immunity, but vaccinations could help “get us closer to filling the herd immunity gap.”
The FDA Advisory Committee plays a key role in approving flu and other vaccines in the US and verifies that the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does. In similar requests from Pfizer and Moderna, the FDA approved the vaccinations of those companies a day after the commission approved emergency use. If J & J’s follow the pattern, a third vaccine could be approved on Saturday.
Following the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and a voting committee member, said J & J’s vaccine will help “meet the needs of the moment,” as states complain. there is insufficient supply of Pfizers and Modernas. vaccines.
“We need to market this vaccine now,” said Dr. Jay Portnoy, a UMKC School of Medicine professor and voting committee member, after the vote. He added, “We are in a hurry,” as the variants threaten the nation’s progress on the pandemic.
Initially, the doses would be limited. The US plans to ship 3 million to 4 million doses of J & J’s vaccine to states, pharmacies and community health centers next week, pending FDA approval, Jeff Zients, President Joe Biden’s Covid Tsar, told Wednesday reporters. The company expects to deliver 20 million doses by the end of March, J & J’s vice president of U.S. medical affairs, Dr. Richard Nettles, told House lawmakers on Tuesday. J&J has a deal 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 the approval of J & J’s vaccine. Unlike the Pfizer and Moderna vaccines, which require two doses three to four weeks apart, J & J’s only require one dose , facilitating logistics for healthcare providers. J & J’s vaccine can also be stored for months at refrigerator temperatures, unlike the two other vaccines that must be stored at freezing temperatures.
J & J’s single-dose vaccine “makes it operationally easier in many contexts,” Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, to the Journal of the American Medical Association at a question-and-answer event on Friday. “I expect a lot of state health department considerations around these vaccines to have more to do with the ease of use of the J&J vaccine and how it may be better suited to some populations.”
An EUA means the FDA will allow some people to receive the vaccine while the agency continues to evaluate data. It is not the same as full approval, which requires more data and can usually take several months longer. J&J, like Pfizer and Moderna, has only submitted two months of safety data, but the agency usually takes six months for full approval. The company is asking the FDA to approve the use of the vaccine in people 18 and older.
J&J submitted its Covid vaccine data to the FDA on Feb. 4. The vaccine’s level of protection varied by region, J&J said, with the shot showing 66% effectiveness overall, 72% in the United States, 66% in Latin America, and 57%. in South Africa, where the B.1.351 variety is spreading rapidly. However, documents from FDA staff show that the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospitalizations and deaths.
The FDA has indicated it would approve a Covid-19 vaccine that is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting the flu by 40% to 60% compared to people who have not been vaccinated, according to the CDC.
FDA staff approved J & J’s vaccine on Wednesday, saying in documents that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19 . “
According to the FDA report, no specific vaccine safety concerns were identified when analyzed for age, race, and co-morbidity. Headaches, fatigue, and muscle aches 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, head of clinical development and medical affairs at J & J’s Janssen vaccine division, told the FDA panel on Friday that two people developed severe allergic reactions shortly after receiving the vaccine. One of the people took part in an ongoing study in South Africa and developed anaphylaxis, a serious and life-threatening allergic reaction.
The FDA report said there were some cases of Bell’s palsy, a condition that causes half of your face to droop, but they were “in balance” with the number generally found in the total population. The FDA had previously said the condition would be monitored in vaccine recipients after it was flagged as a potential problem with Pfizer’s injections, noting that it’s not necessarily a side effect, but worth looking out for.
–CNBCs Hannah Miao contributed to this report.