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Johnson & Johnson’s (J&J) one-dose vaccine for coronavirus disease 2019 (COVID-19) appeared safe and effective in trials, the U.S. Food and Drug Administration (FDA) said Wednesday, raiding the path for approval for emergency use as soon as this. week.
The vaccine was 66% effective in preventing moderate to severe COVID-19 in a global trial of 44,000 people, the FDA said in documents leading up to a Friday meeting of independent experts who will advise the agency on emergency clearance.
New data provided by J&J to the FDA showed the vaccine was 64% effective in stopping moderate to severe COVID-19 cases after 28 days in thousands of trial participants in South Africa, where a worrisome new variant has spread. all over the country.
Overall, the vaccine was 100% effective in stopping hospitalization 28 days after vaccination, compared to 85% at 14 days, and there were no deaths from COVID-19 among those who received the injection instead of a placebo. .
J&J also said the data suggested its vaccine reduced asymptomatic infections, which experts said was another sign that COVID-19 vaccines could stop the transmission of the disease.
“The most encouraging thing for me was the data in South Africa,” said Paul Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia and a member of the FDA advisory committee that will make its recommendation Friday.
“That I could still get protection against doctor-cared illnesses, that is, hospitalization, ICU admission and deaths from that South African strain vaccine, I thought was really encouraging.”
While the FDA is not required to follow the advice of its experts, it approved the Pfizer and Moderna vaccines the day after the advisory committee meeting.
The United States, where COVID-19 has killed more than half a million people, has been struggling to speed up its vaccination program due to the limited supply of Pfizer-BioNTech and Moderna vaccines so far.
Worldwide, COVID-19 has infected 112 million people and killed more than 2.5 million, and governments are rushing to get effective vaccines.
ASYMPTOMATIC TRANSMISSION CUT
J&J said this week that it expected to have 4 million injections ready for use after a green light from the FDA and would ship 20 million doses by the end of March. He promised the United States 100 million doses by the end of June.
The vaccine is administered in a single dose and can be stored in normal refrigerators, unlike Pfizer and Moderna injections that require two doses and must be kept in freezers.
The J&J vaccine is also considered essential in the global vaccination effort due to its routine storage requirements and is already being rolled out for 500,000 healthcare workers in South Africa.
J&J said in documents submitted to the FDA that in a preliminary analysis of its trial, it found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88% efficacy rate.
While fighting asymptomatic infection was not the primary goal of the trial, which studied the vaccine’s ability to stop moderate to severe COVID-19, reducing asymptomatic cases means that injection can also cut transmission of the illness.
“The data is consistent with the fact that these coronavirus vaccines, including the J&J vaccine, have a significant impact on asymptomatic spread,” said Amesh Adalja, principal investigator at the Johns Hopkins Center for Health Safety.
However, he said some public health authorities may ask to see more robust data before being persuaded.
The efficacy of the single-dose vaccine varied over time. In Brazil, where a variant similar to that of South Africa circulates, the vaccine was 66% after 14 days, rising to 68% at 28 days. In the United States, the effectiveness fell from 74% at 14 days to 72% two weeks later.
Overall, only two vaccine recipients developed COVID-19 severe enough to need medical intervention after 14 days and that dropped to zero after 28 days.
J&J has said that it sees an increase in immunity from its vaccine until at least 28 days after the injection. The drugmaker has said it expects sustained, or even improved, protection over time.
SIDE EFFECTS
Three vaccine recipients had serious side effects in the trial that were likely related to the vaccine, but the FDA said its analysis did not raise any specific safety concerns that would prevent the issuance of an emergency use authorization.
The FDA said the most common reactions were injection site pain at 48.6%, headache at 39%, fatigue at 38.2%, and myalgia at 33.2%. Other side effects included fever in 9% of the participants and high fever in 0.2% of those who received the vaccine.
The regulator said a case of pericarditis, a heart disease, may have been caused by the vaccine. He said the cases of a rare disorder, Guillain-Barré syndrome, were unlikely to be related to the injection, although the data was insufficient to determine whether the vaccine had caused these side effects. – Michael Erman / Reuters
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