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Vaccines

COVID-19 vaccine makers sign safety and efficacy pledge

Nine companies vow to wait for Phase III clinical trial data before seeking vaccine approvals

by Ryan Cross
September 10, 2020 | APPEARED IN VOLUME 98, ISSUE 35

 

Chief executives of nine drug companies have signed a pledge“to uphold the integrity of the scientific process” while developing vaccines for COVID-19. The firms also say they will seek regulatory approval of a vaccine only after proving its safety and efficacy in a Phase III clinical trial. Safety will be the “top priority,” the group says.

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These nine firms signed the safety pledge.

AstraZeneca
BioNTech
GlaxoSmithKline
Johnson & Johnson
Merck & Co.
Moderna
Novavax
Pfizer
Sanofi

The pledge is an attempt to bolster public confidence in the vaccines, three of which are currently undergoing testing in large clinical trials of 30,000 people each. A recent survey from USA Today and Suffolk Poll suggests that only 27% of Americans plan to get a COVID-19 vaccine as soon as one is available.

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The US government has already spent about $10 billion to fund R&D for COVID-19 vaccines and pre-order 800 million doses.

The pledge also came amid increasing concerns that US President Donald J. Trump may push for an early vaccine approval in October to boost his chances in the upcoming presidential election. Last month, Trump accused the US Food and Drug Administration of “hoping to delay” the vaccine until after the election. The FDA itself has said it “will not cut corners” when reviewing COVID-19 vaccine data.

The firms emphasize that their vaccines will be vetted by the FDA, but such vetting does not preclude an early release. Pfizer has indicated that its vaccine could receive emergency use authorization (EUA) by the end of October, which would allow distribution to a select group before a formal FDA approval allows wider distribution.

EUAs have been a source of controversy during the pandemic. FDA granted an EUA for chloroquine and hydroxychloroquine in March, but revoked the authorization in June after studies showed the drugs were ineffective in treating COVID-19. And in August the agency came under fire for exaggerating the benefits of convalescent plasma and granting it an EUA, even though randomized clinical trials have yet to show it is effective in treating COVID-19.

Soon after the safety and efficacy pledge was published on Sept. 8, STAT News reported that AstraZeneca had voluntarily halted its vaccine trial after a participant had an adverse event. An anonymous source told the New York Times that the individual was diagnosed with a form of spinal cord inflammation called transverse myelitis. It is not yet known if the condition is linked to the vaccine.

The next day, AstraZeneca confirmed that it had paused the trial due to “a single event of an unexplained illness” but did not offer any more details. The firm suggested that adverse events are to be expected in such a large trial and said that an independent committee would review the safety data.

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