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Pfizer (PFE)/BioNTech Comirnaty Gets FDA's Full Approval

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Pfizer (PFE - Free Report) and its Germany-based partner BioNTech (BNTX - Free Report) announced that the FDA has approved the biologics license application (BLA) for their mRNA-based COVID-19 vaccine, Comirnaty (previously BNT162b2). The vaccine, which was until now approved for emergency/conditional use, has now been granted “full” approval to prevent COVID-19 in individuals 16 years of age and older. The vaccine was granted Emergency Use Authorization (EUA) in the United States for individuals 16 year and older on Dec 11 last year. In May this year, the EUA was expanded to allow the vaccine’s use in adolescents 12 to 15years of age.

With the FDA’s approval of the BLA, Comirnaty becomes the first vaccine,which has been granted full approval by the FDA. The full approval was based on longer-term follow-up data from the vaccine’s phase III study. The companies completed filing of the BLA in Mayand it was granted priority review in July.

The full approval of Pfizer’s vaccine is expected to increase vaccination rates in the United Statesas Americans should now have more faith in the safety and efficacy of the vaccine, which willreduce their hesitancy. The full approval should result in many governments and private corporations and agencies to enforce vaccine mandates on their employees. In the United States, infection cases have crossed the 250,000-new cases per day mark as the pace of infection has gained traction since July mainly due to the spread of the Delta variant.

The higher vaccination rates should, in turn, boost Pfizer/BioNTech’s sales and profits.

Pfizer’s shares were up around 2.5% while BioNTech’s shares were up around 9.6% on Monday, in response to the news. Pfizer’s stock has risen 35.7% this year so far compared with an increase of 19.3% for the industry.

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Image Source: Zacks Investment Research

BioNTech’s stock has risen 368.7% this year so far compared against a decrease of 2% for the industry.

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Image Source: Zacks Investment Research

In fact, Moderna (MRNA - Free Report) , which also markets a mRNA-based COVID-19 vaccine, mRNA-1273 on an emergency basis, saw its stock rise 7.6% on Monday.  J&J’s (JNJ - Free Report) single-shot, adeno-virus-based COVID-19 vaccine, has also been granted EUA by the FDA.

Pfizer/BioNTech’s COVID-19 vaccine is now approved for emergency/temporary in several countries worldwide. Pfizer/BioNTech have already delivered more than a billion doses of BNT162b2 to help vaccinate the global population.They expect to manufacture in total up to 3 billion doses by the end of December 2021 and have agreements (signed through mid-July 2021) in place to deliver 2.1 billion doses in 2021. The companies are also evaluating the vaccine in younger patients, a booster vaccine dose and an updated version of the vaccine specifically designed to target the Delta variant.

Pfizer/BioNTech plan to seek approval for a third, or booster, dose of Comirnaty from the FDA for individuals 16 years of age and older via a supplemental BLA filing (sBLA). It also plans to file a sBLA to seek full approval of the vaccine in the 12-15 years age group once the required data are available. The vaccine was approved for emergency use in adolescents 12-15 years of age in May.

Pfizer and BioNTech both currently have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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