An FDA vaccine advisory panel meets today to discuss whether or not to recommend a COVID-19 vaccine developed by Moderna for Emergency Use Authorization. This follows closely on the heels of FDA authorization of a Pfizer vaccine for emergency use, a product already being administered to thousands of Americans. Depicted by many as magic bullets, the Pfizer and Moderna vaccines are raising the hopes of finally waking from the viral nightmare of SARS-Cov2.
Granting Emergency Use Authorization for Moderna’s jab, however, raises some concerns. Despite the reassurances from public health officials and vaccine advocates that research, development, and approval of these drugs was not hurried, company filings with the U.S. government by these two drug makers tell a different story. At Pfizer, although researchers designed their study to continue for 15 months, a decision was made to announce study outcomes after just 7 months. Moderna, on the other hand, planned a 27-month study but stopped it abruptly after only four months—clear evidence of just how much the science was rushed.
Nevertheless, there is tremendous pressure on FDA regulators to grant Moderna its EUA. According to reports, the U.S. government declined an earlier offer from Pfizer to preorder tens of millions of extra doses of their vaccine, a decision that threatens to bring the entire vaccination program to a screeching halt in March until more product becomes available, possibly in June. Meanwhile, the other options are currently limited. Research from Astrazeneca, the third runner-up, has been discredited to the point that the British-Swedish multinational is considering launching a second clinical trial. And, while there are other candidates, many hail from countries like China or Russia and are highly unlikely choices due to political pressure and negative public opinion.
Assembling the group of experts meeting as this blog entry is being written is clearly just a formality in the authorization process. With an advisory panel comprised primarily of vocal vaccine proponents wooed by authoritative presentations from Moderna representatives and FDA regulators making the case for the effectiveness and safety of the drug, there is little room for dissent. Although concerns from public interest groups and pointed questions on the science from the panel members are again expected, Moderna, like Pfizer, should be able to reasonably deflect problematic queries and plead ignorance wherever necessary. This will allow the FDA, which is expected to give an almost immediate green light to the Moderna jab, to make a specious claim that due diligence has been done.