BioNTech SE (BNTX:NASDAQ) has been asked by the U.S. Food and Drug Administration (FDA) to provide additional data regarding its emergency use application (EUA) for administering COMIRNATY to children aged 6 months to 4 years, reported H.C. Wainwright & Co. analyst Robert Burns in an April 29 research note.
BioNTech's EUA specifically requested approval of the first two COMIRNATY doses (3 micrograms each) of three for this pediatric age group. COMIRNATY is a COVID-19 vaccine that BioNTech and Pfizer are advancing together.
In response to the EUA, the FDA noted it would like to see "additional information about the ongoing evaluation of a third dose" before making a decision. Accordingly, the partnering companies are expected to submit, without delay, data on a third dose, given at least eight weeks after the second one.
"We believe that COMIRNATY should ultimately be granted EUA by the FDA in this age group," Burns wrote.
Also, full trial results for the use of COMIRNATY in 2- to 5-year-old children should be released by mid-2022, added Burns.
In other news, BioNTech and Pfizer recently submitted a separate EUA to the FDA for use of a 10 microgram COMIRNATY booster dose in children aged 5 through 11 years, wrote Burns. In the coming weeks, the two firms will submit similar approval requests to the European Medicines Agency and other vaccine regulating agencies.
Burns also pointed out that BioNTech and Pfizer are advancing a COVID Omicron-specific vaccine through the clinic, too. An initial data readout is expected also by midyear. With this product, BioNTech and Pfizer are close behind Moderna in bringing such a vaccine to market.
Moderna's booster, mRNA-1273.211, demonstrated better initial results than its previous iteration, mRNA-1273, Burns noted. Recently released data showed mRNA-1273.211 to be superior after one month against SARS-CoV-2 and the Beta, Delta, and Omicron variants, and superior after six months against SARS-CoV-2, Beta, and Omicron.
Finally, Burns warned that COVID-19 vaccination numbers are dropping worldwide and the trend could continue.
"We anticipate that changing views towards the COVID-19 public health problem may negatively impact vaccine demand in the coming months," the analyst wrote.
H.C. Wainwright has a Buy rating and a 12-month price target of $298 per share on BioNTech. In comparison, its current share price is less than half of that, at around $143.40.
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