AstraZeneca said the additional study is unlikely to delay regulatory approval in the UK and European Union
The head of UK drug maker AstraZeneca said Thursday that further research into its COVID-19 vaccine was needed after questions about the protection it offers emerged. However, the additional tests should not affect regulatory approval in Europe.
AstraZeneca and its partner, the University of Oxford, announced Monday that they are filing for regulatory approval for the vaccine after it showed an average effectiveness of 70 percent.
That rate rose to 90 percent when an initial half dose and then a full dose were given, similar to competing vaccines developed by Pfizer / BioNTech and Moderna.
However, US scientists have found that the higher rate of effectiveness when tested occurred in people under the age of 55 and was discovered by chance during clinical trials.
Oxford Vaccine Group leader Andrew Pollard said this week that more evidence will be in next month, but the result was still “highly significant”.
“After we find better effectiveness, we need to validate this and do an additional study,” Pascal Soriot, CEO of AstraZeneca, told Bloomberg.
He said he expected this to be another “international study, but this could be faster because we know the effectiveness is high so we need fewer patients”.
The additional attempt shouldn’t delay regulatory approval in the UK and the European Union, Soriot said.
There are high hopes for the AstraZeneca / Oxford vaccine, which Pollard has called “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 for at least six months.
Pfizer / BioNTech’s offering requires temperatures as low as -70 ° C, which increases costs and potentially makes it inaccessible to low- and middle-income countries.
AstraZeneca / Oxford has also promised to make its vaccine available to developing countries for the benefit of the world.
let’s wait and see
The World Health Organization said it looks forward to the full publication of the data from the study.
“By reviewing the detailed data, we are better placed to understand vaccination performance,” it said.
UK Chief Medical Officer Chris Whitty also warned 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 early, especially before the independent regulator has had a chance to look at the results,” he said at a press conference.
Helen Fletcher, professor of immunology at the London School of Hygiene and Tropical Medicine, said the safety data for the vaccine were “very robust”.
“It is possible that a lower initial vaccine dose will make the vaccine more effective … more is not necessarily better when it comes to vaccines and immunotherapies,” she 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 the age distribution in the studies were “not useful to anyone”.
“We have good reason to trust that regulations in this high-profile area are being enforced as carefully or more carefully for these vaccines than for any other in the past,” he said.
Gillies O’Bryan-Tear of the UK School of Pharmaceutical Medicine said “the potential rate of effectiveness may change” but “the validity of the low-dose / high-dose group results is unlikely to be questioned”.
“Even if they (the regulators) decided to ignore the results of the low dose / high dose group, the investigation of the high dose / high dose patients will still be of great importance, but I think it is unlikely,” said he.
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