July 13, 2020 / 11:52 AM / a month ago

Pfizer, BioNTech's coronavirus vaccine candidates get FDA's 'fast track' status

(Reuters) - Pfizer Inc (PFE.N) and partner BioNTech SE (22UAy.F) (BNTX.O) said on Monday two of their experimental coronavirus vaccine candidates received “fast track” status from the U.S. Food and Drug Administration, which is designed to speed up the regulatory review process.

The U.S.-listed shares of the German firm climbed about 15%, while Pfizer’s stock rose about 5%. The news lifted broader market sentiment as investors cheered signs of progress in COVID-19 vaccine development.

The FDA grants fast track status to speed up the review of new drugs and vaccines that show the potential to address unmet medical needs.

The market is “desperate to latch onto any positive developments in the vaccine field,” JP Morgan analyst Cory Kasimov said in a note.

However, Kasimov said, the update was not really surprising or significant, noting that the designation “does not speak to the potential of a particular candidate.”

The benefits of the designation “are almost certainly going to be granted to all potential COVID-19 therapeutics/vaccines anyway,” Kasimov wrote.

The two candidates to win the designation, BNT162b1 and BNT162b2, are the most advanced of the at least four vaccines being assessed by the companies in ongoing trials in the United States and Germany.

Earlier this month, Pfizer and BioNTech said early-stage testing of two dosages of BNT162b1 on 24 healthy volunteers showed that after 28 days they had developed higher levels of COVID-19 antibodies than typically seen in infected people.

The companies said they expect to start a large trial with up to 30,000 participants as soon as later this month, upon regulatory approval.

FILE PHOTO: The headquarters of biopharmaceutical company BioNTech are seen in Mainz, Germany July 31, 2018. REUTERS/Ralph Orlowski

They are gearing up to make up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by end of 2021, if the vaccine is successful.

The companies are in a global race with Moderna Inc (MRNA.O), AstraZeneca Plc (AZN.L) and others to develop a vaccine for COVID-19, the respiratory illness caused by the new coronavirus, which has claimed over 568,500 lives globally, according to a Reuters tally.

Moderna, which is developing a potential vaccine using similar technology as Pfizer/BioNTech, won the same fast-track status for its COVID-19 vaccine candidate in May.

Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru, additional reporting by Ankur Banerjee; Editing by Shinjini Ganguli, Sriraj Kalluvila, Lewis Krauskopf and Richard Chang

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below