The pharmaceutical industry has warned that deviating from proven dosing intervals for Covid-19 vaccines threatens to undermine public confidence in the shot, even if an AstraZeneca director said he supported the strategy.
Major drug lobby groups in the US and Europe said on Wednesday that they supported dosage monitoring that had been assessed in clinical trials.
In a joint statement, the groups warned that “emerging discussions of dosing strategies” may not be supported by drug labels or published data, and that any changes to dosing and vaccination schedules “should follow science and be based on a transparent consideration of the information available. . data”.
The UK has chosen to extend the dosing schedule for the two approved vaccines it currently uses against coronavirus – which are made by BioNTech / Pfizer and Oxford / AstraZeneca – to 12 weeks, sparking fierce scientific debate and criticism from manufacturers.
However, on Wednesday, Mene Pangalos, the executive vice president for biopharmaceutical research and development at AstraZeneca, told UK lawmakers that he was in favor of data suggesting that longer intervals could yield greater efficacy. AstraZeneca is a member of a number of these lobby groups.
“That increased interval between doses actually increases efficacy,” he said, adding that data suggested that individuals were about 70 percent protected after their first dose. He said there were “suggestions that eight to 12 weeks might look even better” in terms of efficacy.
Separately, AstraZeneca said the UK’s decision was supported by ‘strong’ evidence, with the vaccine providing high protection against mild diseases after the first dose and ‘full protection against serious illness and hospitalization’.
Other countries, including Germany and Denmark, have either taken the same approach as the UK or expressed an interest in pursuing it, but with a maximum of six weeks between the first and the follow-up. Crucially, the Oxford / AstraZeneca vaccine is currently only approved for use in the UK.
But US agencies have argued against dose dispersion, with Health Secretary Alex Azar calling it “reckless” on Tuesday and warning the Food and Drug Administration that it is “counterproductive.”
Observers have said that the UK’s “pragmatic” decision highlights the public health need facing the country, given the limited vaccine supply. The 12 week period is significantly longer than the 21 days focused in clinical studies for the BioNTech / Pfizer shot.
Dose spacing has broad theoretical support as it tends to stimulate stronger immune responses. It is also supported by extensive empirical evidence for other vaccines, but not coronavirus.
The World Health Organization and the European Medicines Agency allow a maximum interval of six weeks, although they recommend following the vaccination schedules adopted in trials. Their guidelines are not valid for the Oxford / AstraZeneca vaccine, which showed efficacy rates of as much as 90 percent in November on a dosing regimen that was later abandoned because it was not confirmed by full analysis.
Experts have said that a lack of clear communication about the strategy can lead to hesitation among potential recipients, rendering large-scale vaccination campaigns useless. The approach could also spur the emergence of vaccine-resistant strains, although UK health authorities have said this risk is small, given the potential benefit of achieving broader, if not clinical trial-quality immunity in a larger proportion of the population .
The UK has also made contingency plans to combine different coronavirus vaccines, although health authorities say the approach is not recommended and would only be used in very limited circumstances.
“It is vital to maintain, build and maintain public confidence in Covid-19 vaccination by continuing to make and communicate policy decisions based on robust scientific evidence,” the lobby groups said. their statement. They encouraged more studies to produce better information about the changes.
“Only then can we put an end to this pandemic.”
Additional reporting by Hannah Kuchler in New York
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