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Pfizer (PFE), BioNTech Seek Full Approval for COVID Jab Booster

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Pfizer (PFE - Free Report) and its Germany-based partner BioNTech (BNTX - Free Report) announced that they have begun filing of a supplemental biologics license application (sBLA), seeking approval for a “booster” or third dose of their mRNA-based COVID-19 vaccine, Comirnaty.

The sBLA for the booster dose includes data from a phase III study (n=306), which showed that the booster dose induced significant SARS-CoV-2 neutralizing antibody titers. The antibody levels elicited against the initial SARS-CoV-2 virus (wild type) one month after booster dose were 3.3 times the levels seen one month after the second dose. The vaccine also demonstrated a favorable safety and tolerability profile.

The companies plan to complete the sBLA filing by the end of this week. Pfizer plans to file these data with the European Medicines Agency (EMA) and other regulatory authorities in the next few weeks.

Last week, the companies had informed that they will seek approval for the booster dose in people 16 years of age and older by filing a sBLA pending approval of the formal BLA. The FDA granted “full” or “formal” approval to Comirnaty’s BLA earlier this week prevent COVID-19 in individuals 16 years of age and older. The vaccine was until now approved for emergency/conditional use.

Pfizer’s stock has risen 29.1% this year so far compared with an increase of 17.3% for the industry.

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BioNTech’s stock has risen 361.2% this year so far against a decrease of 0.8% for the industry.

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In the United States, infection cases have crossed the 260,000-new cases per day mark as the pace of infection has gained traction since July mainly due to the spread of the Delta variant. A booster dose, given 6-12 months after the primary two-dose schedule, can help maintain protection against the virus, which can help reduce infection rates among those who have been previously vaccinated.

Though not yet approved as a booster dose, last week, the FDA expanded its emergency use authorization (“EUA”) to allow the third dose to be administered to certain immunocompromised individuals like those who have undergone solid organ transplantation or diagnosed with other diseases that may have weakened their immune systems. Moderna (MRNA - Free Report) , which also markets a mRNA-based COVID-19 vaccine, mRNA-1273, was also granted a similar approval for a third dose. However, an EUA amendment to include immunocompromised individuals in authorized label of J&J’s (JNJ - Free Report) single-shot, adeno-virus-based COVID-19 vaccine was not enacted due to insufficient data. However, J&J, on Wednesday, released data supporting use of the booster shot, which showed that its COVID-19 vaccine booster, after single dose primary regimen, provided rapid and robust increase in spike-binding antibodies.

A couple of weeks back, the U.S. government had said that it intends to begin offering the third shots from both Pfizer and Moderna from Sep20 to those individuals who had taken their initial shots more than eight months ago. But this will be carried out only if the FDA authorizes the booster shots.

Pfizer and BioNTech also plan 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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