Drug giant AstraZeneca updating its data on the efficacy of its coronavirus vaccine, said late Wednesday that the vaccine showed 76% efficacy against symptomatic coronavirus disease while its efficacy was 100% against critical or severe disease or hospitalization.
AstraZeneca Updates Data On Its Covid-19 Vaccine Efficacy
The company added that the vaccine showed 85% efficacy in the prevention of symptoms in volunteers 65 and older.
The figures did not differ much from the ones released by the company in a statement on Monday. As with Monday’s data, it came in a news release and not in a peer-reviewed report. It did not also come as submission to the US Food and Drug Administration for review.
The primary analysis was consistent with the company’s interim analysis released earlier and confirmed that its Covid-19 vaccine was highly effective in adults, including people in the 65 and more age group; Mene Pangalos, executive vice president for biopharmaceuticals research, said in a statement. The statement added that the company looked forward to filing its regulatory submission for Emergency Use Authorization in the US and making available millions of doses across America.
The independent Data and Safety Monitoring Board (DMSB) that reviewed data from multiple Covid-19 vaccine candidates voiced concern over the company’s latest findings’ announcements. Also, in an unusual move, the National Institute of Allergy and Infectious Diseases announced the concerns publicly.
The NIAID, which had helped AstraZeneca run trials in the US, said that the DSMB expressed concern over the company having possibly included information that was outdated from that trial, which might have led to the company providing a view of the efficacy data that was incomplete.
The NIAID called on the company to work with the DSMB to review the efficacy data and ensure that the most up-to-date, most accurate efficacy data was made public as quickly as possible.
On Monday, the company said that its Covid-19 vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization.
The trial involving 32,449 volunteers in Peru, the US, and Chile showed that people who were given the vaccine shot were 76% less likely to show coronavirus symptoms against one-third of participants who had been given a placebo. The vaccine comprised two doses, given four weeks apart.
According to commentators, like other vaccine trials, the company was interested in seeing how many people who had been vaccinated showed Covid-19 symptoms as against unvaccinated people.
The company added the primary analysis involved 190 cases, adding there were 14 additional possible or probable cases for adjudication, so there might be fluctuation in the total number of cases and the point estimate.
It added that the company would also submit the primary analysis for peer-reviewed publication over the coming weeks.
Commentators pointed out that as with other coronavirus vaccine trials, the volunteers had not been tested regularly for Covid-19, so it was not known how many might have had asymptomatic infections.
According to the company, a key secondary endpoint, preventing severe or critical disease and hospitalization, demonstrated 100% efficacy. It added eight cases of severe disease were observed in the primary analysis, with all of those cases in the placebo group.
It added the vaccine had been well tolerated and with no identified safety concerns related to the vaccine.
According to NIAID Director Dr Anthony Fauci, who commented earlier this week on the release of premature data, that it was an unforced error, a sports term meaning it was their own mistake.
On ABC’s Good Morning America, Tuesday, he said the AstraZeneca vaccine was likely a very good candidate, and the situation did nothing but cast doubt about the vaccines and might contribute to vaccine hesitancy.