Pfizer, Inc. PFE and its Germany-based partner, BioNTech BNTX submitted an application for conditional marketing authorization (CMA) to the European Medicines Agency (EMA) for their mRNA-based coronavirus vaccine candidate, BNT162b2. Pfizer had initiated a rolling submission for BNT162b2 to the EMA on Oct 6. The formal CMA submission completes the rolling review process. If EMA, after reviewing the data, concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID-19, it may recommend granting a CMA.

In response to the CMA filing, the EMA said that its Committee for Human Medicines (CHMP) will review the quality, safety and effectiveness of the vaccine and will conclude its assessment by a meeting scheduled for Dec 29. The European Commission, the EU executive body, will give its final decision days after a recommendation by the EMA.

Last week, the companies submitted a request to the FDA to grant emergency use authorization (EUA) to BNT162b2. In addition, the companies have initiated rolling submissions with regulatory agencies in Australia, Canada, Europe, Japan. BNT162b2 got its first approval in the world with U.K. regulatory agency, Medicines & Healthcare Products Regulatory Agency (MHRA) granting it a temporary authorization for emergency use on Wednesday

Pfizer’s stock is up 0.6% this year compared with 0.3% increase for the industry.

BioNTech’s shares are up 236.5% this year compared with the industry’s increase of 3.4%.

Final data from a phase III study on BNT162b2, announced last month, showed that the candidate was 95% effective in preventing COVID-19. The vaccine proved effective across all age groups with the efficacy percentage in adults 65 years and older being over 94%. No serious side effects were observed in the studies.

Pfizer plans to manufacture up to 50 million doses by the end of this year, if approval is received and potentially up to 1.3 billion doses by the end of 2021.

On Monday, rival coronavirus vaccine maker, Moderna MRNA also applied for EUA for its coronavirus vaccine candidate, mRNA-1273, which uses the same mRNA-based technology as Pfizer/BioNTech. Moderna also filed an application for CMA with the EMA. Moderna’s candidate achieved efficacy rate of 94.1% in primary efficacy analysis. Importantly, it showed 100% effectiveness in preventing severe cases of COVID-19.

The FDA scheduled an advisory committee meeting on Dec 10 to discuss Pfizer/BioNTech’s EUA and a similar meeting on Dec 17 to discuss Moderna’s EUA. The FDA should make its decisions soon after the meetings. Both companies seem confident to start delivery of the vaccines immediately after the vaccines receive the approval.

Meanwhile, AstraZeneca AZN/Oxford University’s potential COVID-19 vaccine candidate, AZD1222 was, on an average, about 70% effective in preventing COVID-19, per interim data released from late-stage studies. J&J’s COVID-19 vaccine is also in late-stage development and the company should release data soon.

While Pfizer has a Zacks Rank #3 (Hold), BioNTech has a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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