2021.02.24 16:27
From CNN's John Bonifield
Moderna has designed an updated version of its Covid-19 vaccine to help it combat the South Africa coronavirus variant, the company announced Wednesday.
Initial doses have been shipped to the US National Institutes of Health for a clinical study.
The new vaccine, called mRNA-1273.351, will be evaluated as a booster shot for people who have already been vaccinated against coronavirus and as a primary vaccine for people who haven't had coronavirus and have yet to be vaccinated.
Moderna said it will also evaluate a "multivalent" booster shot that combines the new vaccine formulation with the current vaccine.
Additionally, the company said it has begun to test whether a third, lower dose of its current Covid-19 vaccine can increase immunity against coronavirus variants of concern, with some study participants already getting third doses.
On Monday, the US Food and Drug Administration issued new guidance to vaccine makers to address the emergence of coronavirus variants. The agency recommended that data from clinical immunogenicity studies be used to support any changes or updates to vaccines. Such studies would be smaller and could take less time than large-scale clinical trials.
"It's going to be on the order of a few hundred individuals in terms of size and we'd expect that that might take a few months," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said during a call with reporters on Monday.
Moderna said it plans to "evaluate immunogenicity and safety in participants" consistent with the recently updated guidance.
"We are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic. Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control. We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide many more doses to the global community in late 2021 and 2022 if necessary," Stephane Bancel, Moderna's CEO, said in a news release Wednesday.
Moderna did not say how long it expects the studies to take, or when the new vaccine would be available, if authorized.
2021.02.24 16:41
2021.02.24 17:49
JERUSALEM — The two-dose Covid-19 vaccine developed by Pfizer and BioNTech is protecting recipients about as well in wide actual use as it did in clinical trials, according to a new large-scale study from Israel that was published on Wednesday in The New England Journal of Medicine.
The study, by the Clalit Research Institute, the research arm of Israel’s largest H.M.O. in collaboration with experts from Harvard University and Boston Children’s Hospital, found that the vaccine reduced symptomatic cases by 94 percent a week after the second dose, and reduced severe disease by 92 percent.
The study appears to be the first large-scale, peer-reviewed examination of the vaccine’s performance in general use. It included more than a million people aged 16 and over, nearly 600,000 of whom had been vaccinated, and an equally large, carefully matched control group of unvaccinated individuals.
The results reflect those of earlier studies out of Israel, as well as clinical trials showing a 95 percent efficacy rate for the vaccine.
“You’re never quite sure, after a controlled trial, will it really look like this in the real world?” Dr. Phil R. Dormitzer, vice president and chief scientific officer of viral vaccines at Pfizer, said in an interview. “So that’s some good news.”
Israel’s swift inoculation campaign has outpaced the rest of the world, making the country a kind of test laboratory for the two-dose Pfizer-BioNTech vaccine. More than half the nation’s nine million people have received the first dose, and more than one-third have received both.
The country has universal health care, and about 53 percent of the population is enrolled in Clalit Health Services, giving researchers access to a huge pool of data that could be used to make certain that they were drawing sound conclusions.
“In all studies of vaccine effectiveness, a major challenge is to ensure that those we are comparing to identify the vaccine’s effect are similar in the other characteristics that may predict whether they get infected or ill,” said Prof. Marc Lipsitch of the Harvard T.H. Chan School of Public Health, who took part in the study. “Clalit’s extraordinary database made it possible to design a study that addressed these challenges.”
“We have more than 20 years of fully digitized electronic medical records,” said Prof. Ran Balicer, who directs Clalit’s research institute and is the senior author of the new study.
The study included some 22,000 vaccine recipients aged 80 or above, a much larger sample of this exceedingly high-risk category than Pfizer had in its randomized clinical trials. The new study found no drop in effectiveness for the vaccine among older people.
“This research is a perfect example of how randomized trials and observational health care databases complement each other,” Prof. Miguel Hernán, another Harvard researcher who took part in the study, said in a statement.
The study began when Israel started its vaccination drive on Dec. 20 and continued until Feb. 1 — a period when Israel was going through its third and largest wave of infection, and when the B.1.1.7 variant, first detected in Britain, was becoming the dominant source of new cases in Israel. The study indicated that the vaccine is effective against that variant.
Katie Thomas contributed reporting.
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This is truly encouraging news!
It appears more certain that scientists will conquer the coronavirus
in the foreseeable future.
These scientists involved in mRNA vaccine are truly saviors of mankind.
They deserve the highest award the world can come up with.