The vaccine is already approved for emergency use by people over the age of 16. However, if approved, the vaccine may remain on the market after the pandemic is over. Companies can also sell directly to consumers and change prices.
“After more than 170 million successful doses to the U.S. population in just a few months, (application) submissions are important for achieving long-term herd immunity and containing Covid-19 in the future. It will be the basis, “BioNTech CEO Uğur Shahin said in writing.
BioNTech shares soar with FDA filing
Pfizer and BioNTech received an emergency permit for the Covid vaccine in December. At the time, the FDA said that vaccinated volunteers would need at least 6 months of follow-up data before considering full approval.
The data submitted to the FDA on Friday contains the latest analysis from Phase 3 testing. Pfizer and BioNTech said in a news release that they had observed the safety and efficacy of the vaccine for up to 6 months after the second dose.
“We look forward to working with the FDA to complete this rolling submission and support the review,” Pfizer CEO Albert Bourla said in a statement. Our goal is to ensure the approval of various regulators. “
Next, the FDA must decide whether to accept or reject the application. The agency then sets a date to confirm it. It can also stir up BioNTech strains.
Vaccine strain recovers
The news on Friday was a breath of fresh air for BioNTech stocks.
Shares were under pressure earlier this week after President Joe Biden and his administration expressed support for waiving the Covid vaccine patent. The goal is to help other countries make their own vaccines. As of Thursday’s closing price, BioNTech shares have fallen almost 20% this week.
But on Thursday, German Chancellor Angela Merkel opposed waiving vaccine patent protection. This helped BioNTech, based in Mainz, Germany, reduce far more serious losses. At some point, BioNTech’s inventory fell by 15%.
Follow Allison Gatlin on Twitter. @IBD_AGatlin..
You may like it too:
BioNTech Stockpop: Pfizer, BioNTech seeks FDA approval for Covid vaccine
Source link BioNTech Stockpop: Pfizer, BioNTech seeks FDA approval for Covid vaccine