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LONDON: AstraZeneca and the University of Oxford have more work to do to confirm whether their COVID-19 vaccine can be 90 percent effective, peer-reviewed data published in The Lancet on Tuesday (December 8) showed. , which could slow down your eventual launch in the fight. against the pandemic.
Once seen as the pioneer in the development of a vaccine against the coronavirus crisis, the British team was surpassed by the American pharmaceutical company Pfizer, whose injections, with a success rate of around 95 percent, were administered to retirees of the United Kingdom on Tuesday in a world. Hailed for the first time as V-Day.
The detailed results of the AstraZeneca / Oxford trials have been eagerly awaited after some scientists criticized the lack of information in their initial announcement last month.
However, the Lancet study gave some additional clues as to why the efficacy was 62 percent for trial participants who received two full doses, but 90 percent for a smaller subgroup that received half and then one dose. complete.
“(This) will require more research as more data from the trial becomes available,” the study said.
Fewer than 6 per cent of the UK trial participants received the lowest dose regimen and none of them were over 55 years old, meaning that further research will be needed to investigate the efficacy of the vaccine in older people who are particularly susceptible to COVID-19.
Combining the results, the overall efficacy was 70.4 percent, Tuesday’s data showed. That’s above the 50 percent minimum set by the US Food and Drug Administration.
COVID-19 vaccines from Pfizer and its German partner BioNTech and Moderna have reported efficacy levels of more than 90 percent in late-stage trials.
But the AstraZeneca / Oxford vaccine is considered particularly important in addressing the pandemic in the developing world, as it would be cheaper and easier to distribute.
“The basic message: that the overall efficacy in all the trials reported here is around 70 percent, but with a clear description of its uncertainty,” said Stephen Evans, professor of pharmacoepidemiology at the School of Hygiene and Tropical Medicine. From london.
“The statistical uncertainty is that the efficacy could be as low as 55% or as high as 80%. The Pfizer / BioNTech and Moderna vaccines have efficiencies greater than 90% and are clearly more effective under test conditions.”
When asked whether the half-then full-dose regimen had been a mistake, Andrew Pollard, director of the Oxford Vaccine Group and lead investigator on the trials, told a news conference that it hadn’t been “planned.” .
NEW TEST?
Mene Pangalos, AstraZeneca’s head of non-cancer research and development, said applications for regulatory approval around the world could still be submitted this year.
“We hope that once the data is reviewed by the regulatory authorities, we can get approval at any time from the completion of the submission, which could be anytime from the end of this year to the beginning of next,” he said.
However, Pollard admitted that the different results of the two dosing regimens complicated matters.
“Regulators will decide exactly what your label should say,” he said, when asked if regulators could approve the full two-shot regiment first, and then potentially the half-shot regiment, then the full one, when there is more data.
Pangalos also said he assumed that US regulators would want to see the results of an ongoing trial in the United States before giving approval.
It left open whether an expensive new test was needed, as the company previously said was likely, because more infections in ongoing tests can provide the necessary clarity.
“We have not yet decided what the next study would be, if we do a next study … we will decide in due course.”
SECURITY FIRST
Pfizer overcame the next hurdle in the race to get its vaccine approved for emergency use in the US on Tuesday after the Food and Drug Administration (FDA) released documents that raised no new concerns about its safety or efficacy. .
The Oxford researchers, in turn, said their vaccine was found to be safe, with three of the roughly 23,700 participants experiencing serious conditions that were possibly related to the COVID-19 vaccine or a standard meningitis vaccine given to a control group.
A case of a serious neurological disease, transverse myelitis, was reported 14 days after a booster injection of the COVID-19 vaccine, which “was possibly related to vaccination,” they said.
This case had resulted in a seven-week stay of trial in the United States and brief interruptions in trials in other countries.
In South Africa there was a case of fever above 40 ° C, but it was not revealed whether this participant received the vaccine because the person recovered quickly and continues the test without knowledge of the injection received, as is the norm.
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