Pfizer and BioNTech Covid-19 Vaccine on Track for October Regulatory Review

The Covid-19 vaccine candidate from Pfizer and BioNTech will move into final-stage testing.
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Pfizer  (PFE) - Get Report and its German partner BioNTech  (BNTX) - Get Report were rising in premarket trading Friday after the companies said their Covid-19 vaccine candidate would move into final-stage testing. 

The companies said the vaccine "was well tolerated with mild to moderate fever in fewer than 20% of the participants."

Pfizer and BioNTech said late Thursday they were continuing to analyze data from the Phase 1 trials in the U.S. and Germany.

“The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials," said Kathrin U. Jansen, Pfizer's senior vice president and head of vaccine research and development.

Pfizer rose 1.24% to $39.20 in premarket trading and BioNTech jumped 8.63% to $71.99.

Pfizer last month agreed to provide 600 million doses of its developing coronavirus vaccine to the U.S. government. Pfizer and BioNTech will receive $1.95 billion for the first 100 million doses of their BNT162b2 vaccine, once it is approved by regulators, with the potential for a further 500 million doses to be manufactured thereafter.

More than 160 coronavirus vaccines are under development worldwide, according to the World Health Organization.

Johnson & Johnson  (JNJ) - Get Report next month reportedly plans to begin a late-stage trial testing a potential coronavirus vaccine.

The Phase 3 trial would enroll up to 60,000 healthy people ages 18 and older across nearly 180 locations in the U.S. and other countries, according to ClinicalTrials.gov, a U.S. government database of clinical trials, and CNBC.

“Our Phase 3 program is intended to be as robust as possible, could include up to 60,000 participants and will be conducted in places with high incidence rates,” J&J spokesman Jake Sargent said in a statement to CNBC. 

“We are using epidemiology and modeling data to predict and plan where our studies should take place and expect that to be finalized soon.”

Participants will be randomly selected to receive a dose of the potential vaccine or a placebo.