COVID-19 Vaccine Update – It’s All Eyes on the FDA and BioNTech/Pfizer Inc.

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It’s a big day on the COVID-19 vaccine front, with the FDA scheduled to review BioNTech/Pfizer Inc.’s mRNA vaccine later today.

Lagging behind the UK approval that came last week, there will be plenty of pressure on the FDA to give the approval.

COVID-19 cases across the U.S continues to rise as U.S states make their way through the winter months.

Approval would mean that BioNTech/Pfizer Inc. will be able to begin distributing vaccines as early as the weekend.

Unfortunately, supply chain issues have meant that vaccine production for the year will be as much as 50% lower than initially forecasted.

This means that the continued rise in new COVID-19 cases across the U.S is unlikely to abate anytime soon.

What’s next?

Assuming that the FDA approves BioNTech/Pfizer Inc.’s EUA, the U.S government is due to receive 25 million doses by the end of the year.

That just covers 12.5 million of more than 330 million people living in the U.S.

When considering the CDC’s high priority vaccine recipients, the number of vaccines is not enough to cover the first priority group.

This will leave doctors, nurses, lab technicians, and EMT and hospital staff at risk, not to mention the most vulnerable.

With prioritization ultimately sitting at the state level rather than the Federal level this will leave the most adversely affected states vulnerable to further spikes.

Based on the sheer numbers, Moderna Inc. and AstraZeneca will need to also be in a position to ease demand pressures.

The CDC’s phase sequence leaves adults with high-risk medical conditions and the over 65s in phase 1c.

In phase 1a are healthcare personnel and LTCF residents, with phase 1b including essential workers.

To put it into perspective, the CDC also provided estimate numbers of vaccine recipients within the phase 1a category:

• Healthcare personnel – Approx. 21million.
• Long-term Care Facility Residents (LTCF) – Approx. 3 million.

A total of 25 million BioNTech/Pfizer Inc. doses are not enough to cover healthcare personnel, let alone LTCF and phase 1b and phase 1c recipients.

With Moderna Inc. and AstraZeneca also delivering vaccines, the reality is that a single dose vaccine is needed.

The Latest COVID-19 Numbers

At the time of writing, the total number of confirmed COVID-19 cases stood at 69,381,422. Conditions in the U.S and parts of Europe have continued to deteriorate. The total number of U.S cases has risen to 15,824,444.

India and Brazil have reported a total of 9,767,371 and 6,673,118 cases respectively, sitting behind the U.S as the worst affected.

France (2,324,216), Italy (1,770,149), Spain (1,725,473), and Germany (1,245,729) are also in desperate need of a vaccine. For the EU, however, vaccine reviews are not due until next month.

Other Pharmas

While BioNTech/Pfizer Inc. and Moderna Inc. are leading the race, there is a desperate need for more vaccines.

In reality, there is not only the need for more vaccines but single-dose vaccines.

This week, Johnson & Johnson announced that results from clinical trials will be released earlier than previously expected.

More good news is going to be needed for there to be a credible threat to the COVID-19 pandemic.

Trust issues mean that vaccines from countries such as China and Russia would unlikely be considered for review.

This leaves the door ajar for the rest of the major pharmas to deliver. These include but are not limited to the following:

U.S Headquartered

Mateon Therapeutics: Listed on OTCMKTS (“MATN”) and headquartered in California.

Merck & Co.: Listed on the New York Stock Exchange (“MRK”) and headquartered in New Jersey, USA.

Moderna Inc.: Listed on the NASDAQ (“MRNA”) and headquartered in Cambridge, Massachusetts, USA.

Pfizer Inc.: Listed on the New York Stock Exchange (“PFE”) and headquartered in New York City. (Pfizer Inc. has partnered with Germany’s BioNTech SE)

Sorrento Therapeutics: Listed on the NASDAQ (“SRNE”) and headquartered in California. Currently trailing many of the front runners in the race for an effective vaccine.

Talem Therapeutics: This is a wholly-owned subsidiary of ImmunoPrecise Antibodies USA. Its parent company, ImmunoPrecise Antibodies Ltd is listed on the Toronto Stock Exchange.

Tonix Pharmaceuticals: Listed on the NASDAQ (“TNXP”) and headquartered in New Jersey.

Europe Headquartered

AstraZeneca: Listed on the London Stock Exchange (“AZN”) and headquartered in Cambridge, England and Sodertalje, Sweden.

GlaxoSmithKline: Listed on the London Stock Exchange (“GSK”) and headquartered in Brentford, England.

Grifols, S.A: Listed on the Bolsa de Madrid (“GRF”) and headquartered in Barcelona, Spain.

Asia Headquartered:

GC Pharma: Listed on the Korea Stock Exchange (“006280”) and headquartered in Yongin, South Korea.

The Global Financial Markets

Progress by the leading pharmas continues to support riskier assets. Hopes of other pharmas completing successful trials have also provided support.

Clinical trial results, however, will need to deliver impressive numbers for a global end to the COVID-19 pandemic.

Failure for other pharmas to begin rolling out vaccines will test support for riskier assets.

The sheer numbers needing vaccines on the front line mean that other high priority recipients remain exposed. Therefore, a credible threat remains to the likes of the EU and beyond that have fallen behind Britain, and possibly the U.S, on approving effective vaccines for circulation.