Reality Check For COVID Vaccines: Caution Moderna, BioNTech, Novavax

Summary

• Crunch time coming for the COVID-19 vaccine developments.
• Manufacture, scale-up, distribution, pricing all actioned before any vaccine shown to be safe or effective.
• FDA independence has been questioned, with consequences for public acceptance if a vaccine gets approved.
• AstraZeneca/Oxford University Phase 3 trial has been paused due to adverse event.
• Caution needed as vaccine stocks might see a reversal.

Source: abc news

Vaccines take time to develop because they need to be very safe and also effective. It comes as no surprise (especially for coronavirus vaccine development) that the path to development will involve some findings that need careful consideration. Hence news that the AstraZeneca (NYSE:AZN)/Oxford University Phase 3 trial has been paused is a reality check. Some will be dismayed because this was perceived to be a front runner for a vaccine.

The summary is that expecting to have a vaccine approved (even under a EUA) before November 3 is an impossible task, unless the rules are torn up. We are in uncharted territory here, but as I explain below, forcing through approval might backfire in terms of combating the pandemic. Investors hoping for big gains from vaccine approval may need to calm down for a bit.

Perceived FDA interference raises problems

There have been recent instances of apparent political interference in the activities of the FDA, involving FDA approvals in spite of expert concern.

Convalescent plasma: Notwithstanding that convalescent plasma has been used to treat more than 70,000 COVID patients, in the absence of trial data it is no surprise that there was expert pushback from the recent FDA EUA (Emergency Use Approval) for use of convalescent plasma to treat COVID-19. There is a long history in drug/vaccine development showing the need for randomised trials to prove effectiveness and safety.

Indeed a randomized trial involving 464 moderately ill COVID-19 patients in 39 Indian hospitals has concluded that convalescent plasma provided no benefit in reducing 28-day mortality or progression to severe COVID-19. This study indicated that only two randomised clinical trials on convalescent plasma have been published. One from China was halted due to inadequate enrolments, while a Dutch study was halted because of the need for redesign based on interim

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