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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 hold across the country .
The FDA’s emergency use clearance on Saturday kicks off the federal government’s plan to distribute nearly 4 million doses of J&J vaccine to states, pharmacies and community health centers across the country next week . Unlike the vaccines from Pfizer and Moderna, the J&J single dose regimen eliminates the need for patients to come back for a second dose and it can be stored at refrigerator temperature for months.
J & J’s vaccine “makes operations easier in many settings,” Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Disease, told the Journal of the American Medical Association at an event. questions and answers Friday. “I expect that a lot of the considerations state health departments will have around these vaccines are more about how easy the J&J vaccine is to use and how it might be better suited for certain populations. “
Initially, the doses would be limited, J&J said. The company plans to deliver 20 million doses by the end of March, J&J Vice President of U.S. Medical Affairs Dr. Richard Nettles told House lawmakers on Tuesday. J&J has reached 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 increase supply as quickly as possible .
In recent weeks, US health officials have urged Americans to get vaccinated as quickly as possible. Officials are increasingly concerned about new emerging variants of the virus, particularly strain B.1.351, which has been shown to reduce the effectiveness of vaccines both on the market and under development. On Friday, the head of the Centers for Disease Control and Prevention, Dr Rochelle Walensky, warned that the drop in Covid-19 cases reported in the United States since early January could fade as the variants spread.
J&J submitted its data on the Covid vaccine to the FDA on February 4. The vaccine’s level of protection varied by region, J&J said, with the shot demonstrating an overall effectiveness of 66%, 72% in the United States, 66% in Latin America and 57% in South Africa, where variant B. 1,351 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 in preventing Covid-19, while Moderna’s was found to be around 94% effective. Infectious disease experts have pointed out that J&J’s figures cannot be used as a direct comparison to the other two vaccines because it is a single dose and the company’s trial was conducted when ‘there were more infections as well as new, more contagious variants.
The FDA has said it will allow a Covid-19 vaccine that is at least 50% safe and effective. The flu shot, by comparison, typically reduces the risk of getting the flu by 40% to 60% compared to people who are not vaccinated, according to the CDC.
The FDA has cleared the J & J’s vaccine for people 18 years of age 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, only submitted two months of safety data, but the agency typically needs six months for full approval. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March, only to revoke it in June after additional data showed it provided “no evidence of benefit” in patients with coronavirus.
The FDA was due to approve J & J’s vaccine for emergency use.
The agency’s announcement comes after a key panel on Friday unanimously supported the vaccine for emergency use.The FDA’s Advisory Committee on Vaccines and Related Biologics plays a key role in the approval of influenza and other vaccines in the United States, verifying that the vaccines are safe for public use. Although the FDA does not have to follow the advisory committee’s recommendation, it often does.
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 day” as states complain it doesn’t there are not enough Pfizer and Moderna. vaccines.
“We have to get this vaccine out now,” Dr Jay Portnoy, UMKC medical school professor and voting committee member, said after the vote. He added, “we are in a hurry” as the variants pose a threat to the nation’s progress on the pandemic.
No specific safety concerns with J & J’s vaccine have been identified. Headaches, fatigue and muscle aches were among the most common side effects in people who received the inoculation, according to an FDA report released Wednesday. There have also been reports of nausea, fever and pain at the injection site, according to the report.
Macaya Douoguih, head of clinical development and medical affairs at J&J’s vaccine division, Janssen, told the FDA panel on Friday that two people suffered severe allergic reactions shortly after receiving the vaccine. One of the people was in an ongoing trial in South Africa and developed anaphylaxis, a serious and life-threatening allergic reaction.
The company has announced plans to ship the vaccine, which contains five doses per vial, between 36 and 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 its vaccine for two weeks at temperatures commonly found in pharmaceutical freezers. Moderna’s vaccine should be shipped between 13 degrees and 5 degrees above zero Fahrenheit.
This is a developing story. Please come back for updates.
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