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LONDON, UNITED KINGDOM – The head of British drug manufacturer AstraZeneca said Thursday that more research on its COVID-19 vaccine is needed after questions have emerged about the protection it offers, but additional testing is unlikely to affect regulatory approval in Europe.
AstraZeneca and its partner, the University of Oxford, announced Monday that it was seeking regulatory approval for the vaccine after it showed an average efficacy of 70 percent.
This rate jumped to 90% when an initial half dose and then a full dose was administered, similar to rival vaccines under development from Pfizer / BioNTech and Moderna.
But the US scientists said the highest rate of effectiveness came when tested on people aged 55 and under and was discovered by accident during clinical trials.
Oxford Vaccine Group chief Andrew Pollard said this week that further evidence will be available next month, but the result is still “highly significant.”
“Now that we have found what appears to be better efficacy, we need to validate it, so we need to do an additional study,” Pascal Soriot, chief executive of AstraZeneca, told Bloomberg.
He said he expected it to be another “international study, but this could be faster because we know efficacy is high, so we need fewer patients.”
The additional process should not have delayed regulatory approval in Britain and the European Union, Soriot said.
There are high hopes for the AstraZeneca / Oxford vaccine, which Pollard hailed as a “vaccine for the world” as it may be cheaper to manufacture and easier to store and distribute.
It can be stored, transported and handled under normal refrigeration conditions between two and eight degrees Celsius (36-46 Fahrenheit) for at least six months.
Pfizer / BioNTech’s offering requires temperatures as low as -70 ° C, increasing costs and making it potentially out of reach for middle and low income countries.
AstraZeneca / Oxford has also pledged to supply its vaccine to non-profit developing countries.
WAIT AND SEE
The World Health Organization said it was looking forward to the full publication of the study data.
“After a review of the detailed data, we will be in a better position to understand the vaccine’s performance,” he said.
The chief medical officer for England, Chris Whitty, also cautioned against drawing premature conclusions and urged patience until the data was published in peer-reviewed journals.
“It is always a mistake to make too many judgments in advance and particularly before the independent regulator has had a chance to look at the results,” he said at a news conference.
Helen Fletcher, professor of immunology at the London School of Hygiene and Tropical Medicine, said the available safety data on the vaccine were “very robust”.
“It is possible that a lower starting dose of vaccine may result in greater vaccine efficacy … More is not necessarily better when it comes to vaccines and immunotherapies,” he said.
“It is also possible that a strong immune response to the first vaccine could effectively block an immune response to the second shot of the same virus.”
Fletcher’s colleague, professor of pharmacoepidemiology Stephen Evans, said speculations about age distribution in the studies “were of no use to anyone.”
“We have good reason to trust that regulation in this high-profile sector will be done with the same or more attention to these vaccines than any other in the past,” he said.
Gillies O’Bryan-Tear, of the UK Faculty of Pharmaceutical Medicine, said “the ultimate efficacy rate may change,” but “the validity of the results from the low / high dose group is unlikely to be questioned. “.
“Even if they (the regulators) decide to ignore the results of the low dose / high dose group, the study of high dose / high dose patients will still be highly significant, but I think that is unlikely,” he said.
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