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How Quickly Could Vaccines Targeting the Omicron Variant Be Available?

By Keith Speights and Brian Orelli, PhD – Dec 11, 2021 at 12:35PM

Key Points

  • DNA and mRNA vaccines targeting the omicron variant can be manufactured relatively quickly.
  • The FDA's data requirements will determine how soon variant-specific vaccines could be available.
  • If the FDA only requires data showing antibody levels, some vaccines could be ready by March 2022.

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It depends on what data the FDA requires.

It's possible that booster doses will be all that's required to prevent infection from 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 recorded on Dec. 1, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss how quickly these omicron-targeting vaccines might be available.

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Keith Speights: Brian, let's stay on this subject a little while longer. Several companies have already begun efforts to develop COVID-19 vaccines that specifically target this omicron variant. Realistically though, how quickly could these targeted vaccines be authorized by the FDA?

Brian Orelli: Yet, it's not that hard to create an mRNA or a DNA molecule that contains the new omicron sequence. So mRNA companies, that's Pfizer (PFE -0.31%) and BioNTech (BNTX -3.63%) and then Moderna (MRNA -2.07%) and the companies that are using adenoviruses, which uses DNA to express the protein, that's AstraZeneca (AZN 1.84%) and Johnson and Johnson (JNJ 0.43%), they should be able to make the new vaccines fairly quickly.

I saw BioNTech thinks that it can have initial batches within a 100 days. Manufacturing is pretty straightforward. The question I think is, what level of data is the FDA going to want? Will antibody levels be sufficient? Those would only take maybe a couple of months at the most to enroll a clinical trial and then getting antibody levels after a few weeks or a month.

Then, or is the agency going to want efficacy data showing that the new vaccine prevents infection, and that could take substantially longer, I think depending on the infection rate at the start of the clinical trial.

Speights: Any predictions on what the FDA might require?

Orelli: I think based on the fact that they only require the antibody levels for boosters, I'm going to guess that they would only require antibody levels for omicron, but I think it's the boosters is sort of a different animal than a new variant, and so I don't know what they would require.

I think it might depend on the level of omicron being around. If it's not a major problem, then I think probably antibody levels is probably going to be sufficient, if it's a major problem, then maybe they are going to require showing that it can lower infection rates, but that will mean that it's also a lot easier to show that it lowers infection rates because we're all getting infected even though we already have immunization to the original strain, then it will be fairly easy for them to show that the infection rate goes down because a lot of people are being 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 they just going to require. I think I saw one of the CEOs or I think one of the executives of one of the vaccine makers were speculating that they could get authorization as early as March 2022. Now that's pure conjecture at this point. But does that sound about right? Do you think that's even realistic?

Orelli: I think that's probably realistic based on if they only need antibodies definitely.

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

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