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Post by Admin on Jan 29, 2021 20:48:12 GMT
Johnson & Johnson said Friday its single-dose coronavirus vaccine was 66% effective overall in protecting against Covid-19. The vaccine, however, appeared to be less potent against other variants.
The Food and Drug Administration has indicated it would authorize a vaccine that’s safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the Centers for Disease Control and Prevention.
The level of protection varied by region, J&J said, with the vaccine demonstrating 66% effectiveness overall, 72% in the United States, 66% in Latin America and 57% in South Africa after four weeks.
J&J said the vaccine was 85% effective in preventing severe disease four weeks after vaccination in all adults. The vaccine offered complete protection against Covid-related hospitalizations four weeks after vaccination, the company said.
“We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere,” J&J CEO Alex Gorsky said in a statement.
Shares of J&J were down about 4% in midday trading following the announcement and amid a broader market selloff. Shares of Novavax, which is also developing a Covid-19 vaccine, were up about 65% midday, and Moderna shares were up 9%.
The highly anticipated results were based on 468 confirmed Covid-19 infections among the phase three trial’s more than 43,000 volunteers, according to J&J. The company said the trial includes those infected with B.1.351, the new, highly contagious strain found in South Africa.
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Post by Admin on Jan 31, 2021 4:21:50 GMT
Johnson & Johnson says their COVID-19 vaccine, which only requires one shot rather than two, is 72% effective at preventing COVID-19 in the United States and 85% effective against severe symptoms. That’s less effective than Pfizer’s and Moderna’s vaccines, but Johnson & Johnson says no one who received their vaccine went to the hospital or died. Dr. Anthony Fauci says the one-shot vaccine adds “to the whole effort of getting more vaccine candidates into the mix.” NBC’s Meagan Fitzgerald reports for Weekend TODAY.
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Post by Admin on Apr 13, 2021 19:07:11 GMT
The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson's Covid-19 vaccine over six reported US cases of a "rare and severe" type of blood clot. The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States. All six cases occurred among women ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to a joint statement from the CDC and FDA. Dr. Carlos Del Rio and CNN's Dr. Sanjay Gupta discuss the announcement. #CNN #News
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Post by Admin on Apr 14, 2021 5:01:25 GMT
The Food and Drug Administration said Tuesday it is asking states to temporarily halt using Johnson & Johnson’s Covid-19 vaccine after six people in the U.S. developed a rare blood clotting disorder. Dr. Kavita Patel, fellow at the Brookings Institution, joined "Squawk Box" to discuss the news.
The Food and Drug Administration asked states on Tuesday to temporarily halt using Johnson & Johnson’s Covid-19 vaccine “out of an abundance of caution” after six women in the U.S. developed a rare blood-clotting disorder that left one woman dead and another in critical condition.
“Right now, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
All six cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the shot. Doctors typically treat that type of blood clot with heparin, but health regulators noted that could be dangerous in this case and recommended a different treatment.
J&J said in a statement that “no clear causal relationship” has been identified between the blood clots and the vaccine, adding it is working closely with regulators to assess the data.
People who got the J&J vaccine more than a month ago are at very low risk for developing the blood clots, Dr. Anne Schuchat, the principal deputy director of the CDC, told reporters on a conference call Tuesday.
“For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms,” she said. “If you’ve received the vaccine and developed severe headaches, abdominal pain, leg pain or shortness of breathe you should contact your healthcare provider and seek medical treatment.”
The blood clotting generally occurs about a week after vaccination, but not more than three weeks after, with a median timeframe of 9 days, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said on the call.
“We know that for these vaccines, that for the first several days after vaccination, there are flu-like symptoms that can include headache,” he said, adding that those are likely common adverse events. “It would be more likely if someone presented to an emergency room with very severe headache or blood clots, that a history of vaccination be elicited” and a plan of care put in place. If the patient also has low platelets, doctors should consider that it may be related to the vaccine, he said.
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Post by Admin on Apr 14, 2021 22:10:01 GMT
Former President Donald Trump released a statement Tuesday criticizing the Food and Drug Administration's recommendation to pause the use of the Johnson & Johnson COVID-19 vaccine, baselessly suggesting the decision was politically motivated.
"The results of this vaccine have been extraordinary, but now it's [sic] reputation will be permanently challenged," Trump said. He then floated, without any evidence, that the FDA may have been playing favorites. "[The FDA] should not be able to do such damage for possibly political reasons, or maybe because their friends at Pfizer have suggested it," he said. He also didn't lose an opportunity to bring up his favorite subject: his loss in the 2020 presidential election, which he has blamed on everyone from the Supreme Court to other Republican politicians to the pharmaceutical companies that worked with his administration to craft a vaccine. "Remember, it was the FDA working with Pfizer, who announced the vaccine approval two days after the 2020 presidential election," he said in his Tuesday statement.
He then finished off the statement by boasting about vaccine development under his administration, and called for the Johnson & Johnson shot to be back in action quickly.
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