Don’t blink: The dynamics of the vaccination race against the coronavirus change so fast that you might be missing something. Potential wealth rides on what happened.
According to the World Health Organization, 48 COVID-19 vaccines are currently in clinical testing. Not all of them are potential candidates to reach the U.S. market. Several of the experimental vaccines are being developed by companies whose shares are not public.
Plenty of coronavirus vaccine preparation kits are available to investors. Here is an update on how the situation is currently in terms of leading COVID vaccine stocks.
They are facing licensing decisions
There are two clear leaders in the competition for coronavirus vaccines. Both are awaiting decisions from the U.S. Food and Drug Administration (FDA) Emergency Use Permit (EUA).
Pfizer‘s (NYSE: PFE) and BioNTech‘s (NASDAQ: BNTX) BNT162b2 is already actually shipped, although the EUA is still in progress. Doses of the vaccine fly from Pfizer’s manufacturing facility in Belgium to Chicago and then to distribution centers in the United States. The plan is to deliver vaccine doses ready to the dosing sites as soon as possible as soon as the FDA makes its decision.
This decision is right here. The FDA will convene an Advisory Committee meeting on December 10 to review EUA’s application for BNT162b2. The agency will have to announce shortly afterwards whether Pfizer’s vaccine will receive the EUA.
Modern (NASDAQ: MRNA) it will not be far behind. Biotechnology submitted mRNA-1273 to the EUR on 30 November after reporting earlier in the day that the experimental vaccine was 100% effective in preventing severe cases of COVID-19. The FDA Advisory Committee is scheduled to meet to examine Moderna’s EUA submission on Dec. 17.
Based on the efficacy and safety data reported so far, both vaccines appear to have a good chance of emerging.
The second wave
Three other COVID-19 vaccines could lead to EUA in the first half of 2021. AstraZeneca (NASDAQ: AZN) the only company in this group to have reported interim efficacy results so far in a late-stage study. The large drug manufacturer reported an average transient efficacy of 70% for AZD1222. The details of AstraZeneca’s interim results were interesting.
AstraZeneca gave some participants in the late-stage study a half dose of AZD1222 followed by a full dose at least one month later. This group achieved 90% efficiency. However, this group was much smaller than the group that gave a full dose of AZD1222 and then increased a full dose at least a month later. The efficiency of this larger group was much lower at 62%.
While AstraZeneca is preparing to submit for early approval based on these results in some countries, it may not yet be able to submit itself to the EUA. Why? The reported results are not from the company’s late-stage study of AZD1222 in the United States. In addition, AstraZeneca did not originally include a combined half- and full-dose in the U.S. study, but is now planning to do so.
Johnson & Johnson (NYSE: JNJ) He is currently conducting two global late-stage clinical trials with the COVID-19 vaccine candidate, JNJ-78436735 – one in a single dose and the other in two doses. Like the AstraZeneca AZD1222, the J&J vaccine uses a non-proliferating adenovirus to insert DNA into cells. This DNA contains instructions for producing a protein that is identical to the spike protein on the surface of the new coronavirus that causes COVID-19.
It is too early to know how effective the J&J experimental vaccine will be. The health giant has not given a specific date when interim efficacy results will be available, but sometime in early 2021 it seems likely.
Novavax (NASDAQ: NVAX) another company in the late stages of the COVID-19 vaccine candidate that investors want to see. Biotechnology is expected to announce the interim results of a late-stage British study of its vaccine, NVX-CoV2373, early next year. Novavax had hoped to begin a late-stage study in the United States by the end of November, but recently reported a delay with the FDA in resolving manufacturing issues. The company now plans to begin studying the late phase of NVX-CoV2373 in the United States and Mexico in the coming weeks.
Next stage, late stage
Three COVID-19 vaccine candidates are currently being tested. Two are being developed by Chinese pharmaceutical companies and are unlikely to be present in the United States or major European markets. CureVac (NASDAQ: CVAC)however, it has already concluded an agreement with the European Union to supply at least 225 million doses of the COvID-19 vaccine CVnCoV.
Like Pfizer and BioNTech BNT162b2 and Moderna mRNA1273, CVnCoV uses messenger RNA (mRNA) to direct cells to produce proteins identical to the spike protein on the surface of SARS-CoV-2. CureVac plans to begin Phase 2b / 3 testing of CVnCoV soon, pending regulatory approval. If all progress is on schedule, an interim analysis could be made in the first quarter of 2021.
More winners are likely
Even though Pfizer / BioNTech and Moderna are currently the leaders, don’t look for the all-encompassing scenario with COVID-19 vaccines. More winners are likely.
Of the large drug stocks, Pfizer is probably the biggest winner, at least initially. AstraZeneca and Johnson & Johnson have promised to make their coronavirus vaccines available costly in a pandemic; Pfizer doesn’t. However, J&J can enjoy a competitive advantage with its single-dose vaccine if it proves to be safe and highly effective.
Returning to the relatively small biotechnology stocks, Novavax seems to have the largest head. It is by far the fewest of the leading COVID vaccine manufacturers, with a market cap of less than $ 10 billion. However, Novavax has still not reported interim efficacy results. If NVX-CoV2373 does not result in 90% or more efficiency in the ballpark, Novavax may fall.
The following weeks and months could cause significant shocks in the COVID-19 vaccine landscape. Stay with us.