• Dr. Soumi Eachempati

When are we getting a vaccine for Covid-19?

With 500,000 new Covid-19 cases in the US over the past week, many communities have become on edge. Headlines of Covid-19 related shutdowns such as curfews in certain parts of Texas, business closures in New Jersey, and mask mandates in previously unregulated areas such as North Dakota appear to be on the upswing. Naturally, with all this simultaneous evidence of poor control, questions about the proximity for a Covid-19 vaccine are increasing.

Due to past guidance from the FDA, the pharmaceutical companies, and the White House, there was fodder to hope that some positive vaccine news would occur by the election. Naturally, any optimism from the White House was taken with varying degrees of validity but the other sources created grounds for legitimate vaccine advances. The FDA had long ago announced it was convening a special advisory board on October 22, 2020 to discuss vaccines. Multiple trials were already in Phase 3 and their company sponsors had guided that interim analyses was going to be done regularly after a certain number of events. These analyses would be scrutinized to see if the vaccines gave substantial benefit over placebo in decreasing new Covid-19 cases. If the vaccine showed substantive benefit, the trial could even be stopped and the vaccine made available earlier than expected.

The FDA vaccine advisory committee met on October 22 as scheduled. However, no company submitted data for review in any of the late stage vaccine trials. The absence of any meaningful data meant that either not enough Covid-19 related events had occurred in the trials to warrant in-depth interim analyses or there was not signal showing a demonstrable benefit for the vaccine as of yet. The lack of sufficient patient accrual could have been another issue. Two trials, that of Astra-Zeneca and Johnson and Johnson, were placed on hold several weeks earlier for examination of adverse events. (Those trials have just been restarted). At any rate, the committee met and simply reinforced the guidelines for vaccine approval.

Without any vaccine approval news from the FDA meeting, other timelines have to be examined for an understanding of when vaccines will be available. Pfizer has stated that it will have news regarding vaccines after the third week of November. If the data at this time are strong, one should assume that the FDA will provide an Emergency Use Authorization (EUA) within several weeks, which could be early December in a fastest case. Moderna should reveal vaccine data in December, so potentially a vaccine by January. Novovax would be next and have data in the first quarter of 2021. Astra-Zeneca and Johnson and Johnson are wildcards in that they would have had data potentially by January but were both delayed. The former company, Astra-Zeneca, actually had the quickest timeline before their study was put on international hold earlier in this year.

In aggregate, the earliest a vaccine could be rolled out would in December. However, the initial 10-20 million doses would almost certainly be reserved for health care workers, first responders, other essential personnel, and potentially vulnerable members of society. The general population would be looking at the first or second quarter of 2021 at the earliest.

The need for social distancing and mask wearing is keeping everyone frustrated with the status quo. With the flu season arriving, a potential silver lining could be that this Covid-19 based necessity will decrease standard flu numbers. In the meantime, waiting and hoping for a safe and effective vaccine is unlikely to be the holiday present for too many individuals this December.

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