KEY POINTS

  • Operation Warp Speed is spending billions of dollars to fast-track the development of COVID-19 vaccines
  • Health experts estimate at least four of the vaccines being supported will fail
  • The Trump Administration remains confident at least one safe and effective vaccine will be available by the end of the year 

Historic data suggests at least four of the COVID-19 vaccines currently being supported by the Trump Administration's coronavirus task force might fail the critical "phase three" clinical trials.

In a draft report, the National Academies of Sciences, Engineering, and Medicine (NASEM) said it expects four of the vaccines being developed by companies taking part in Operation Warp Speed (OWS) will fail.

The failures are expected to take place during the key phase three trials when up to 30,000 volunteers are inoculated with the new vaccine. NASEM said OWS expects to support seven vaccines candidates with billion-dollar grants.

The OWS's current vaccine candidates are from Johnson & Johnson (Janssen Pharmaceutical), AstraZeneca-University of Oxford and Vaccitech, Pfizer-BioNTech, Moderna, Merck and IAVI, Vaxart, Inovio, Novavax, and Sanofi and GSK.

Candidate vaccines from Pfizer, Moderna and AstraZeneca have all entered phase three trials. In phase three, thousands of people worldwide are generally inoculated with a new vaccine to test the drug's efficacy and safety.

The Trump Administration said it remains confident at least one safe and effective vaccine will be available by the end of the year and possibly more than one by early 2021. President Donald Trump has even hinted a vaccine might be available in time for the November election.

“Four of the trials will fail, and all subjects in those trials are offered access to an approved vaccine,” wrote NASEM. “Three of the trials will succeed, and, under a 1:1 ratio between members of treatment groups compared to the placebo group, 15,000 participants from each of those trials who were assigned to the placebo condition are offered and approved vaccine.”

coronavirus vaccine A vaccine is pictured. Photo: Pete Linforth - Pixabay

NASEM is basing its estimates, in part, on a study published in the scientific journal Biostatistics stating that vaccines for infectious diseases have a 33.4% success rate of making it through clinical trials and to regulatory approval.

OWS has made million-dollar grants over past few months. In June, it awarded $1.2 billion to AstraZeneca and $483 million to Moderna. The awards in July were even larger. OWS agreed to pay $1.6 billion to Novavax to produce 100 million doses of its candidate vaccine, NVX-CoV2373, if clinical trials are successful. Pfizer and BioNTech received an order of $2 billion to produce 100 million doses of its BNT162b2 vaccine candidate. Sanofi and GSK received $2.1 billion to fund its vaccine candidate.

OWS' goal is to deliver 300 million doses of safe and effective COVID-19 vaccines by the end of the year. Overseeing OWS are Health and Human Services Secretary Alex M. Azar and Defense Secretary Mark Esper.