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FILE PHOTO: A vaccine-labeled test tube is seen in front of the AstraZeneca logo in this illustration taken on September 9, 2020. REUTERS / Dado Ruvic
The head of British drug maker AstraZeneca said Thursday that more research is needed on its COVID-19 vaccine after questions arose 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 they were seeking regulatory approval for the vaccine after it showed an average effectiveness of 70 percent.
That rate jumped to 90 percent when a starting half dose and then a full dose were administered, similar to rival vaccines in development by Pfizer / BioNTech and Moderna.
But American scientists have said that the highest rate of effectiveness occurred during testing in people 55 and younger, and was discovered by accident during clinical trials.
The director of the Oxford Vaccine Group, Andrew Pollard, said this week that more evidence will be available next month, but that the result remains “very significant.”
“Now that we’ve found what looks like better efficacy, we have to validate this, so we need to do an additional study,” AstraZeneca CEO Pascal Soriot told Bloomberg.
He said he hoped it would be another “international study, but this one could be faster because we know the efficacy is high, so we need fewer patients.”
The additional trial is not likely to delay regulatory approval in Britain and the European Union, Soriot said.
There are high hopes for the AstraZeneca / Oxford vaccine, which Pollard has hailed as a “vaccine for the world” given that it could be cheaper to manufacture and easier to store and distribute.
It can be stored, transported and handled under normal refrigeration conditions of between two and eight degrees Celsius (36-46 Fahrenheit) for at least six months.
The Pfizer / BioNTech offering calls for temperatures of -70 ° C, which increases costs and potentially makes it out of reach for low- and middle-income countries.
AstraZeneca / Oxford is also committed to providing its vaccine to the developing world on a non-profit basis.
Wait and see
The World Health Organization said it looked forward to the full release of the trial data.
“In a review of the detailed data, we will be better positioned to understand the performance of the vaccine,” he said.
England’s chief medical officer Chris Whitty also cautioned against drawing premature conclusions and urged patience until the data is published in peer-reviewed journals.
“It is always a mistake to make too many judgments early and in particular before the independent regulator has had a chance to see the results,” he told a news conference.
Helen Fletcher, a professor of immunology at the London School of Hygiene and Tropical Medicine, said the available safety data on the vaccine had been “very strong.”
“It’s possible that a lower starting vaccine dose could result in higher 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 can effectively block an immune response to the second injection of the same virus.”
Fletcher’s colleague, professor of pharmacoepidemiology Stephen Evans, said speculations about the age distribution in the trials “were not helpful to anyone.”
“We have good reason to trust that regulation in this high-profile area will be done with the same or more care for these vaccines than for any others in the past,” he said.
Gillies O’Bryan-Tear from the UK College of Pharmaceutical Medicine said that “the final efficacy rate may change” but “the validity of the results from the low dose / high dose group is unlikely to be questioned “.
“Even if they (regulators) decide to ignore the results of the low dose / high dose group, the study of the high dose / high dose patients will still be very significant, but I think it is unlikely,” he said.
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