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BioNTech (BNTX)/ Pfizer to Seek FDA Nod for COVID-19 Booster

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BioNTech SE (BNTX - Free Report) and its partner pharma giant Pfizer (PFE - Free Report) announced that they are planning to get authorization for a COVID-19 booster vaccine shot, which is a third dose of their currently authorized COVID-19 vaccine BNT162b2, in the United States.

The companies are working on an updated booster shot of BNT162b2 which has the potential to provide higher protection against the new, highly contagious variant of COVID-19, Delta (B.1.617.2). The Delta variant was first found in India, and is rapidly spreading to other parts of the world, increasing the risk of infections across the globe. The variant is now found in more than 100 countries, including the United States.

Per the U.S. Centers for Disease Control and Prevention, the Delta variant has become the most dominant strain in the United States, accounting for majority of new COVID-19 cases in the country. The World Health Organization has warned that Delta will become the globally dominant variant of the coronavirus in the coming months.

Notably, BioNTech/Pfizer announced that a third dose of BNT162b2, administered six months after the second dose, demonstrated a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta variant of the virus. As a result, it provides five to 10 times higher protection than after the second dose of BNT162b2.

Importantly, data published in Nature showed that the immune sera obtained shortly after the second dose of BNT162b2 have strong neutralization titers against the Delta variant. BioNTech/Pfizer believe that a third dose of BNT162b2 will boost those antibody titers even higher.

An increase in the number of cases linked to the Delta variant may cause more severe disease, especially among the unvaccinated people, which can lead to more hospitalizations, and potentially result in more deaths.

Shares of BioNTech have skyrocketed 155.1% so far this year against the industry’s decrease of 2.2%.
 

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Presently, apart from BioNTech/Pfizer’s BNT162b2, Moderna’s (MRNA - Free Report) mRNA-1273 and J&J’s (JNJ - Free Report) single-shot COVID-19 vaccine are available in the United States. AstraZeneca’s vaccine (called Vaxzevria in EU), although available in several countries including India, has not yet been launched in the United States.

In early July, J&J announced new data from studies that demonstrated that its one-shot COVID-19 vaccine generated strong neutralizing antibody activity against the Delta variant. In late June, Moderna announced new results from in vitro neutralization studies on sera from individuals vaccinated with its COVID-19 vaccine, mRNA-1273. Data showed that vaccination with mRNA-1273 can produce a neutralizing effect against all COVID-19 variants tested, including Delta.

Zacks Rank

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

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