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In a press release Monday, the pharmaceutical giant announced that its vaccine is on average 70% effective. However, the company did not indicate the data that led them to this conclusion.
“Without knowing it, it’s hard to know the significance of their findings,” said Dr. Paul Offit, a member of the FDA’s Vaccines and Associated Biologics Advisory Committee, which will review Covid-19 vaccines before they are put on the market. the market.
When two other pharmaceutical companies, Pfizer and Moderna, released their efficacy results earlier this month, they included the data that led to their results.
In its Monday press release, AstraZeneca presented an analysis of 23,000 participants in its Phase 3 trial.
Some participants received the Covid-19 vaccine, while others received a different type of vaccine or placebo injections – saline injections that do nothing.
Next, an independent expert committee determined to what extent the group that received the Covid-19 vaccine was protected against the disease.
In its press release, AstraZeneca said a total of 131 study participants developed Covid-19 but did not specify how many of those people received the Covid-19 vaccine and how many did not. .
AstraZeneca is conducting vaccine trials in collaboration with the University of Oxford in the UK. Spokesmen for the company and the university did not respond to questions from CNN on Monday.
Experts also had questions about the safety of the AstraZeneca vaccine.
The AstraZeneca trial has been suspended twice because government regulators were concerned about two study participants who became seriously ill. Regulators subsequently allowed the trial to resume.
“I would like to know the data specifically on these serious side effects that led to the suspension of the trial,” said Dr. William Schaffner, member of the CDC’s Advisory Committee on Immunization Practices, who will also review vaccines before they are allowed on the market.
In its press release, AstraZeneca said “no serious vaccine-related safety events have been confirmed” and the vaccine was “well tolerated”.
The experts had another question on the AstraZeneca trial.
Among the study participants who received the Covid-19 vaccine, there were two different dosing schedules.
In one regimen, 2,741 participants received a half dose of the vaccine and then a full dose at least a month later. In the second group, 8,895 participants received a full dose followed by another full dose at least one month later.
The group that received the half-dose initially was 90% protected against Covid-19, and the group that received two full doses was only 62% protected.
One of Oxford’s leading researchers, Dr Adrian Hill, said it would take “probably weeks and months” to understand why the lower dose works much better.
“We don’t quite understand this, but there are several ideas for how this might work, and we’re exploring them,” Hill told CNN’s Becky Anderson on Monday.
Vaccine trials are still ongoing in several countries and will eventually include fewer than 60,000 study participants by the end of the year, according to the AstraZeneca press release.
Dr Saad Omer, a vaccine specialist at the Yale School of Medicine, noted that the group with the 90% efficacy rate was relatively small – only 2,741 study participants – and that these results might not hold up when more people are receiving this diet. .
He noted a lack of clarity on several aspects of AstraZeneca’s data.
“I hate to criticize my college colleagues, or anyone for that matter, but posting information like this is like asking us to try and read the tea leaves,” Omer said.
Sierra Jenkins of CNN Health contributed to this story.
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