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COVID vaccine producers pledge to stick to normal rules

September 9, 2020

German vaccine maker BioNTech and eight biotech companies have vowed to follow safety measures before rolling out vaccines. AstraZeneca has suspended one trial after "a potentially unexplained illness" in a participant.

https://p.dw.com/p/3iBmK
A medical worker holds a syringe with a flu vaccine in a mobile flu vaccination center in central Moscow
Image: picture-alliance/dpa/Tass/V. Prokofyev

Several companies developing vaccines to combat the novel coronavirus pandemic on Tuesday pledged to "uphold the integrity of the scientific process" amid growing concerns they could succumb to political pressure.

"We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles," said the chief executives of AstraZeneca, BioNTech and Moderna, among others.

Public health authorities have touted a successful vaccine as the only remedy to the deadly pathogen, which has infected 28 million people and left nearly one million others dead across the globe.

The companies said they would only seek emergency authorizations for their vaccines "after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities."

Earlier this year, the US Food and Drug Administrator (FDA) approved the use of hydroxychloroquine and blood plasma to treat coronavirus patients, triggering a backlash from experts who argued there was not sufficient scientific evidence to prove their safe efficacy. The FDA reversed these decisions shortly after.

Read more: COVID-19 vaccine: From the lab to your doorstep

Oxford/AstraZeneca trial on hold

AstraZeneca, one of the co-signers of the open pledge, told a US outlet that trials of their vaccine candidate were temporarily suspended after a patient fell seriously ill.

Dubbed the Oxford vaccine, AstraZeneca's AZD1222 went into Phase 3 clinical trials — considered the last step before regulatory approval — in the UK, US and Brazil late last month.

"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," an AstraZeneca spokesperson told health news website STAT.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

Brazil's health authority said later on Tuesday that AstraZeneca had halted the clinical trial and that it was waiting for more information on why, seemingly corroborating the report in STAT.

Read more: Global race to buy coronavirus vaccine: What you need to know

ls/msh (AFP, AP, dpa)