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 permit begins Saturday with the federal government’s plan to distribute nearly 4 million doses of J&J vaccine to states, pharmacies and community health centers across the nation next week. Unlike Pfizer and Moderna vaccines, the single-dose J&J regimen eliminates the need for patients to return for the second dose and can be stored in the refrigerator for months.
J & J’s vaccine “makes it easier operationally in many contexts,” Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, told the Journal of the American Medical Association at a question and answer event. Friday. “I expect a lot of the considerations that state health departments have around these vaccines are more about the ease of use of the J&J vaccine and how it might be more appropriate for some populations.”
Initially, the doses would be limited, J&J said. The company expects to deliver 20 million doses by the end of March, House Vice President of Medical Affairs Dr. Richard Nettles told House lawmakers on Tuesday. J&J has an agreement with the US government to supply 100 million doses of vaccine by the end of June, and US officials say they are working with the company to increase supply as soon as possible.
In recent weeks, US health officials have pushed Americans to get vaccinated as soon as possible. Officials are increasingly concerned about new emerging variants of the virus, in particular strain B.1.351, which has been shown to reduce the effectiveness of vaccines both on the market and in developing countries. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, warned that the decline in Covid-19 cases reported in the US since early January could flatten as variants spread.
J&J submitted its Covid vaccine data to the FDA on February 4th. The level of vaccine protection varied by region, J&J said, with one hit demonstrating 66% overall effectiveness, 72% in the United States, 66% in Latin America and 57% in South Africa, where variant B.1.351 spreads 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.
The Pfizer vaccine has been shown to be 95% effective against preventing Covid-19, while Moderna has been shown to be approximately 94% effective. Infectious disease experts have pointed out that the J&J number cannot be used as a direct comparison with the other two vaccines because it is a single dose, and the company’s study was conducted when there were more infections as well as new, more contagious variants. .
The FDA has indicated that it will authorize a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of people getting the flu by 40% to 60%, compared to people who are not inoculated, according to the CDC.
The FDA has approved the J&J vaccine for people 18 years of age and older. It is not the same with full approval, which requires more data and can usually take several months. J&J, like Pfizer and Moderna, submitted only two months of safety data, but the agency usually requires six months for full approval. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March, only to withdraw it in June, after additional data showed that it did not provide “any evidence of benefit” to coronavirus patients.
The FDA was expected to approve the J&J vaccine for emergency use.
The agency’s announcement comes after a key group unanimously backed the emergency vaccine on Friday. . Although the FDA does not have to follow the recommendations of the advisory committee, it often does.
After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and a voting member of the committee, said the J&J vaccine will help “meet the needs of the moment,” as states complain that there is not enough. by Pfizer and Moderna. vaccines.
“We need to get this vaccine out now,” said Dr. Jay Portnoy, a professor at UMKC School of Medicine and a voting member of the committee after the vote. He added, “We are in a hurry,” because the options pose a threat to the nation’s progress on the pandemic.
No specific safety issues have been identified in the J&J vaccine. Headaches, fatigue and muscle aches have been some of the most common side effects among people receiving the inoculation, according to an FDA report released 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 for J & J’s vaccine division Janssen, told the FDA on Friday that two people had severe allergic reactions shortly after the vaccine was given. One of the people took part in an ongoing trial in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.
The company said it plans to deliver the vaccine, which contains five doses per bottle, at 36 to 46 degrees Fahrenheit. By comparison, the Pfizer vaccine should be stored in ultra-cold freezers, which keep it between minus 112 and minus 76 degrees Fahrenheit, although the FDA recently allowed the company to keep its vaccine for two weeks at temperatures commonly found in pharmaceutical freezers. The Moderna vaccine should be transported at 13 below 5 degrees above zero Fahrenheit.
This is a developing story. Please check again for updates.