How quickly might vaccines targeting the Omicron variant be available?

IBooster doses may be sufficient to prevent infection with the omicron variant. However, several major vaccine makers are still moving forward with plans to develop vaccines that specifically target the new variant. In this Motley Fool Live video registered on December 1, 2021Motley Fool contributors Keith Speights and Brian Orelli discuss how quickly these omicron-targeting vaccines might become available.

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Keith Speights: Brian, let’s stay on this topic for a bit. Several companies have already started efforts to develop COVID-19 vaccines that specifically target this omicron variant. Realistically though, how quickly could these targeted vaccines be cleared by the FDA?

Brian Orelli: Yet, it is not that difficult to create an mRNA or a DNA molecule that contains the new omicron sequence. So mRNA companies is Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) then Modern (NASDAQ: mRNA) and companies that use adenoviruses, that use DNA to express the protein, it’s AstraZeneca (NASDAQ: AZN) and Johnson and Johnson (NYSE: JNJ), they should be able to manufacture the new vaccines fairly quickly.

I saw that BioNTech thinks it can have initial batches within 100 days. The manufacture is quite simple. The question I’m thinking is, what level of data is the FDA going to want? Will the antibody levels be sufficient? These might only take a few months at most to enroll in a clinical trial and then get antibody levels after a few weeks or a month.

Then, or will the agency want efficacy data showing that the new vaccine prevents infection, and it could take a lot longer, I think depending on the rate of infection at the start of the trial? clinical.

Speights: Any predictions on what the FDA might require?

Orelli: I think based on the fact that they only need the antibody levels for the boosters, I’m going to assume that they would only need the antibody levels for omicron, but I think that the boosters are sort of a different animal from a new variant, and so I don’t know what they would need.

I think it might depend on the level of omicron present. If it’s not a major problem then I think the antibody levels will probably be enough, if it’s a major problem then maybe they will demand to show that it can reduce the levels of infection, but that will mean that it is also much easier to show that it reduces infection rates because we are all infected even though we are already vaccinated against the original strain then it will be quite easy for them to show that the infection rate goes down because so many people are infected.

Speights: Yeah. There are a lot of variables that come into play here as to how quickly the FDA will move here and how much it’s just going to charge. I think I saw one of the CEOs or I think one of the executives of one of the vaccine makers was speculating that they might get clearance as early as March 2022. Now that’s pure guesswork at this point. But does that sound fair? Do you think it’s even realistic?

Orelli: I think it’s probably realistic if they just need antibodies definitely.

Brian Orelli, PhD has no position in any of the stocks mentioned. Keith Speights is the owner of Pfizer. The Motley Fool recommends Johnson & Johnson and Moderna Inc. The Motley Fool has a disclosure policy.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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