COVID-19 Vaccine Unlikely to be Available Before Presidential Election

Two leading COVID-19 vaccine developers, AstraZeneca and Moderna, have hit new speed bumps that could delay their promising COVID-19 vaccine candidates, reducing the possibility of a vaccine being ready ahead of the U.S. presidential election on Nov. 3.

The FDA has broadened its already-significant investigation into the halted phase 3 trial of AstraZeneca’s AZD1222 after a participant in the UK experienced a serious adverse event. The agency is reportedly asking for data from previous studies of similar vaccines that the same researchers worked on.

“We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the U.S. trial,” an AstraZeneca spokesperson told FDAnews, noting that phase 3 trials in the UK, Brazil and South Africa have already resumed.

One bright spot: the European Medicines Agency said it has begun a review of the AstraZeneca vaccine. The EMA’s Committee for Medicinal Products for Human Use (CHMP) decided to start the “rolling” review based on “preliminary results from nonclinical and early clinical studies suggesting that the vaccine triggers the production of antibodies and T cells” that target the virus.

Meanwhile, Moderna CEO Stéphane Bancel said this week that he doesn’t expect the company to ask the FDA for an Emergency Use Authorization (EUA) for its vaccine before Nov. 25 at the earliest. He had previously indicated that the vaccine could be ready by early November. Bancel says the company just does not have enough supporting data to file for a EUA yet.

He now also estimates that a full approval of the vaccine would take place no sooner than late in the first quarter or early in the second quarter of 2021. Moderna has released the second interim analysis from a phase 1 study of its mRNA-1273, led by the National Institute of Allergy and Infectious Diseases that is evaluating a two-dose regimen of the messenger RNA vaccine. The analysis shows that both 25 and 100 µg doses were generally well-tolerated and generated neutralizing antibodies. — Martin Berman-Gorvine