The pharmaceutical industry has warned of any deviation from proven dosing intervals for Covid-19 vaccines, saying it would risk compromising public confidence in the vaccines.
Major pharmaceutical lobby groups in the US and Europe said on Wednesday they supported “adherence to the dosage that has been evaluated in clinical trials” and that “emerging discussions regarding dosage strategies” may not be supported by drug labels or published data.
Any changes in dosing and inoculation schedules “must follow science and be based on transparent deliberation of available data,” said international and European federations of pharmaceutical manufacturers and associations and US industry groups BIO and PhRMA in a statement. joint press release.
The UK has chosen to extend the dosing schedule for the two approved vaccines it is currently rolling out against the coronavirus – those manufactured by BioNTech / Pfizer and Oxford / AstraZeneca – to 12 weeks, sparking a fierce and compelling scientific debate critical manufacturers.
Other countries, including Germany and Denmark, have either taken the same approach or expressed an interest in continuing it, but with a maximum of six weeks between the first and the follow-up.
But US agencies have opposed the spacing of doses, with Health Secretary Alex Azar calling it “reckless” on Tuesday and the Food and Drug Administration warning it as “counterproductive”.
Observers said that the UK “pragmatic”The decision highlights the public health need facing the country in the midst of limited vaccine supply. The 12 week gap is considerably longer than the 21 days targeted in clinical trials for the Pfizer jab.
Dose spacing has broad theoretical support as it tends to stimulate stronger immune responses. It is also supported by large-scale empirical evidence for other vaccines, although it is not for the 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 the trials. Their guidelines do not apply to the Oxford / AstraZeneca vaccine, which is only approved in the UK. AstraZeneca is a member of some of these lobby groups.
Experts said a lack of clear communication around the strategy could cause hesitation among potential recipients, rendering large-scale vaccination campaigns unnecessary. The approach could also stimulate the emergence of vaccine-resistant strains, although UK health officials have said this risk is low given the potential benefit of achieving broader, if not clinical-trial-grade immunity. , in a larger part of the population.
The UK has also developed contingency plans for mix different coronavirus vaccines, although health officials say the approach is not recommended and would only be used in extremely limited circumstances.
“It is vital to preserve, strengthen and maintain public confidence in the vaccination against Covid-19 by continuing to make and communicate policy decisions based on sound scientific evidence,” the lobby groups said in their declaration. They encouraged more studies to produce better information about the changes.
“Only then can we end this pandemic.”
Additional reporting by Hannah Kuchler in New York