AGL 8.00 Decreased By ▼ -0.15 (-1.84%)
ANL 11.32 Increased By ▲ 0.23 (2.07%)
AVN 83.45 Decreased By ▼ -0.25 (-0.3%)
BOP 5.85 No Change ▼ 0.00 (0%)
CNERGY 5.85 Increased By ▲ 0.20 (3.54%)
EFERT 80.10 Decreased By ▼ -0.12 (-0.15%)
EPCL 67.29 Increased By ▲ 0.01 (0.01%)
FCCL 15.20 No Change ▼ 0.00 (0%)
FFL 7.04 Decreased By ▼ -0.19 (-2.63%)
FLYNG 7.77 Decreased By ▼ -0.29 (-3.6%)
GGGL 11.90 Decreased By ▼ -0.10 (-0.83%)
GGL 17.65 Decreased By ▼ -0.06 (-0.34%)
GTECH 9.18 Increased By ▲ 0.40 (4.56%)
HUMNL 7.20 Decreased By ▼ -0.03 (-0.41%)
KEL 3.50 Decreased By ▼ -0.24 (-6.42%)
LOTCHEM 30.95 Decreased By ▼ -1.15 (-3.58%)
MLCF 28.52 Decreased By ▼ -0.48 (-1.66%)
OGDC 85.20 Decreased By ▼ -0.85 (-0.99%)
PAEL 17.11 Decreased By ▼ -0.29 (-1.67%)
PIBTL 6.15 Decreased By ▼ -0.15 (-2.38%)
PRL 19.84 Increased By ▲ 0.74 (3.87%)
SILK 1.29 Increased By ▲ 0.10 (8.4%)
TELE 12.05 Decreased By ▼ -0.20 (-1.63%)
TPL 9.16 Decreased By ▼ -0.02 (-0.22%)
TPLP 20.19 Decreased By ▼ -0.51 (-2.46%)
TREET 27.10 Increased By ▲ 0.15 (0.56%)
TRG 97.30 Decreased By ▼ -0.45 (-0.46%)
UNITY 22.83 Decreased By ▼ -0.17 (-0.74%)
WAVES 13.29 Decreased By ▼ -0.81 (-5.74%)
WTL 1.45 Increased By ▲ 0.14 (10.69%)
BR100 4,361 Decreased By -27.2 (-0.62%)
BR30 16,009 Decreased By -90.5 (-0.56%)
KSE100 43,482 Decreased By -195.1 (-0.45%)
KSE30 16,476 Decreased By -56.6 (-0.34%)
Business & Finance

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

  • The candidates, 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.
  • Early data from the German trial of BNT162b1 are expected to be released in July, the companies said.
Published July 13, 2020

Two experimental coronavirus vaccines jointly developed by German biotech firm BioNTech and US pharmaceutical giant Pfizer have received 'fast track' designation from the US drug regulator, the companies said on Monday.

The candidates, 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.

Pfizer's shares were up about 2% and US-listed shares of BioNTech were up about 6% before the bell.

Earlier this month, the companies said BNT162b1 showed potential against the virus and was found to be well tolerated in early-stage human trials.

Early data from the German trial of BNT162b1 are expected to be released in July, the companies said.

If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies said they expect to make up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by 2021-end. The companies said they expect to begin a large trial with up to 30,000 participants as soon as later this month, if they receive regulatory approval.

The fast track status by the Food and Drug Administration is granted to speed up the review of new drugs and vaccines that show the potential to address unmet medical needs.

Comments

Comments are closed.