The Food and Drug Administration has approved it Johnson & JohnsonCovid-19 vaccine for emergency use, giving the United States a third pandemic to fight as highly contagious variants begin to take root across the country.
FDA approval for emergency use on Saturday launched a federal government plan to distribute nearly 4 million doses of J&J vaccine to states, pharmacies and community health centers across the country next week. Unlike Pfizeris and ModernVaccinated, J & J’s single-dose regimen eliminates the need for patients to return for another dose and can be stored at refrigerator temperature for months.
J & J’s vaccine “makes it operationally easier in many contexts,” said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, for the Journal of the American Medical Association on Friday at a Q&A event. “I expect a lot of the considerations that state health ministries have about these vaccines to say more about the ease of use of the J&J vaccine and how it might be more appropriate for some populations.”
Initially, doses would be limited, J&J said. The company expects to deliver 20 million doses by the end of March, said on Tuesday the vice president of the American medical sector, J&J, Dr. Richard Nettles. J&J has an agreement with the U.S. government to deliver 100 million doses of its vaccine by the end of June, and U.S. officials say they are working with the company to increase inventory as soon as possible.
In recent weeks, American health workers have pushed Americans to get vaccinated as soon as possible. Officials are increasingly concerned about new, new versions of the virus, especially strain B.1.351, which has been shown to reduce the effectiveness of vaccines both in the market and in the production phase. On Friday, the head of the Center for Disease Control and Prevention, Dr. Rochelle Walensky, warned reported falls in Covid-19 cases in the U.S. from the beginning of January it can be aligned as the variants expand.
J&J submitted his data on the Covid vaccine FDA February 4th. The level of vaccine protection varied by region, J&J said, and the bullet showed an overall efficiency of 66%, 72% in the United States, 66% in Latin America and 57% in South Africa, where the B.1.351 variant 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% hospitalizations and deaths.
Pfizer’s vaccine was found to be 95% effective in preventing Covid-19, while Moderna was found to be about 94% effective. Infectious disease experts pointed out that the J&J numbers could not be used as a direct comparison to the other two vaccines because it was a single dose, and the company was tested when there were more infections, as well as new, more contagious variants.
The FDA has announced that it will approve a Covid-19 vaccine that is at least 50% safe and effective. In comparison, the flu vaccine generally reduces the risk of flu in humans 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. This 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 security data, but the agency typically needs six months for full approval. The FDA approved emergency use of hydroxychloroquine for the treatment of Covid-19 in March, to recall it in June after additional data showed it provided “no evidence of benefit” in patients with coronavirus.
The FDA was expected to approve J & J’s emergency vaccine.
The agency’s announcement comes after a key panel on Friday unanimously supported the emergency vaccine The FDA’s Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the U.S., confirming that vaccines are safe for public use. Although the FDA does not have to follow the recommendations of the advisory board, it often does.
After the vote, dr. Archana Chatterjee, an infectious disease expert at Chicago School of Medicine and a member of the voting committee, said J & J’s vaccine would help “meet current needs” as states complain there is not enough supply of Pfizer and Modern vaccines.
“We need to get this vaccine right away,” said Dr. Jay Portnoy, a professor at the UMKC School of Medicine and a board member with the right to vote, after the vote. He added, “we are in a hurry” because the variants pose a threat to the nation’s progress in the pandemic.
No particular concerns have been identified for the safety of the J&J vaccine. Headaches, fatigue and muscle aches were some of the most common side effects among people who received 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 at J & J’s Janssen vaccines department, told the FDA on Friday that two people suffered serious allergic reactions shortly after receiving the vaccine. One of the people participated in an ongoing trial in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.
The company said it plans to send the vaccine, which contains five doses per bottle, to 36 to 46 degrees Fahrenheit. For comparison, the Pfizer vaccine must 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 store its vaccine for two weeks at temperatures common in pharmaceutical freezers. Modern vaccine must be delivered at a temperature of 13 to 5 degrees Celsius.
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