The Food and Drug Administration has approved Johnson & Johnson’s Covid-19 vaccine for emergency use, giving the United States a third tool to fight the pandemic as highly contagious variants begin to take root across the country.
The FDA’s emergency use authorization on Saturday kicks off the federal government’s plan to distribute nearly 4 million doses of J & J’s vaccine to states, pharmacies and community health centers across the country next week. Unlike Pfizer and Moderna’s vaccines, the J&J single dose regimen eliminates the need for patients to return for a second dose and can be stored at refrigerator temperatures for months.
J & J’s 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.”
Initially, the doses would be limited, J&J said. 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, and US officials say they are working with the company to ramp up delivery as soon as possible.
In recent weeks, US health officials have been pushing Americans to get vaccinated as soon as possible. Officials are increasingly concerned about new, emerging variants of the virus, particularly the B.1.351 strain, which has been shown to reduce the effectiveness of vaccines both on the market and in development. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, that the decline in Covid-19 cases reported in the US since early January is flattening as variants spread.
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, FDA documents 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.
Pfizer’s vaccine was found to be 95% effective against Covid-19, while Moderna was found to be about 94% effective. Infectious disease experts pointed out that J & J’s numbers cannot be used as a direct comparison to the other two vaccines as it is a single dose and the company’s test was conducted when there were more infections and also new, more contagious varieties.
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.
The FDA has approved J & J’s vaccine for people 18 and older. 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 FDA approved the use of hydroxychloroquine in the emergency treatment of Covid-19 in March, to withdraw it in June after additional data showed it showed “no evidence of benefit” in coronavirus patients.
The FDA was expected to approve J & J’s vaccine for emergency use.
The agency’s announcement comes after a key panel unanimously backed the emergency vaccine on Friday. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does.
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.
No specific safety concerns of J & J’s vaccine were identified. Headaches, fatigue, and muscle pain were some of the most common side effects in people who received the vaccination, according to an FDA report published Wednesday. There were also reports of nausea, fever and pain at the injection site, the report said.
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 company has said it plans to ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, although the FDA recently allowed the company to store the vaccine for two weeks at temperatures commonly found in pharmaceuticals. freezers. Moderna’s vaccine should be shipped with a temperature of 13 to 5 degrees above zero Fahrenheit.
This is a story in progress. Please check again for updates.