What Pfizer, BioNTech Investors Need To Know About COVID-19 Vaccine With Conditional UK Approval

What Pfizer, BioNTech Investors Need To Know About COVID-19 Vaccine With Conditional UK Approval

Pfizer Inc. PFE-BioNTech SE – ADR BNTX earned the distinction of being the first companies to receive regulatory authorization for emergency use of their investigational coronavirus vaccine candidate BNT162b2 following a positive verdict from the United Kingdom's drug regulator.

Here's what investors should know about the combo's vaccine candidate:

Pfizer, BioNTech's COVID-19 Vaccine Timeline

March 17: Pfizer and its German partner BioNTech announce a joint vaccine program to develop an mRNA shot, with the program codenamed BNT162.

April 9: Further details released suggest the German company will supply multiple candidates for human testing. The terms of the agreement call for BioNTech receiving an upfront payment of $185 million, including an equity investment of $113 million, and future potential milestone payments up to $563 million, for total consideration of $748 million.

Late April: Clinical trial of multiple candidates begin in Germany.

May 5: The U.S. leg of a Phase 1/2 trial begins. 

July 1: Pfizer and BioNTech announce positive preliminary data from the U.S. Phase 1/2 study of BNT162b1 — one of the four vaccine candidates evaluated.

July 13: Two of the vaccine candidates — BNT162b1 and BNT162b1 — receive fast track designation from the FDA.

July 20: The companies announce early positive data from the German leg of the Phase 1/2 study.

July 22: The U.S. government agrees to buy up to 600 million doses of the vaccine candidate.

July 27: The companies choose BNT162b2 as their lead candidate and commence the Phase 2/3 global study.

July 31: The companies announce a vaccine supply deal with Japan to supply 120 million doses. 

Aug. 8: Canada clinches a vaccine supply deal, although the quantity and other terms were not disclosed.

Aug. 20: The companies shares additional positive early data.

Oct. 6: Rolling BLA submission to the EMA initiated.

Oct. 9: Rolling BLA submission initiated in Canada.

Nov. 11: The companies report positive interim data from the Phase 3 study. A 200-million-dose vaccine supply deal is announced with the European Union.

Nov. 18: The Phase 3 study concludes. 

Nov. 20: The companies file for emergency use authorization with the FDA.

Dec. 1: Pfizer-BioNTech file for conditional marketing authorization approval in Europe

Dec. 2: The U.K.'s Medicines & Healthcare Products Regulatory Agency issues a temporary authorization for emergency use of the vaccine candidate. The U.K. expects to have about 800,000 doses starting next week.

Related Link: The Week Ahead In Biotech: Hematology Conference Gets Underway, Vanda And BioCryst Await FDA Decisions

The Pfizer-BioNTech Vaccine Candidate: The investigational vaccine from the U.S.-German combo belongs to a new breed of vaccines.

Traditional vaccines use dead or weakened pathogens that can trigger a strong immune response without causing the disease.

An mRNA — or messenger RNA — vaccine tricks the body into producing some of the viral proteins to produce an immune response.

To produce a mRNA vaccine, a synthetic version of mRNA that is used by a virus to build the proteins used for infection is produced. This mRNA, when delivered into the human body, serves as instructions to build the viral protein.

BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein, which is the target of virus-neutralizing antibodies.

Pfizer, BioNTech's Efficacy, Safety Data: Primary analysis of safety and efficacy data from the Phase 3 study showed a vaccine efficacy rate of 95% based on 170 events.

Efficacy was consistent across age, gender, race and ethnicity demographics. For adults over 65 who are considered a high-risk population, efficacy was a robust 94%.

Among the 10 severe cases observed, nine were in the placebo arm and one was in the BNT162b2 arm.

The vaccine candidate was well-tolerated in the study, which evaluated 43,000 volunteers, with no serious adverse concerns observed.

The Vaccine Dose: A two-dose regimen given 21 days apart is envisaged.

Pfizer, BioNTech's Vaccine Manufacturing Plan: Pfizer and BioNTech said they aim to produce about 50 million vaccine doses globally by 2020 and up to 1.3 billion doses by 2021.

Four of Pfizer's facilities — St. Louis, Missouri, Andover, Massachusetts, Kalamazoo, Michigan and Puurs, Belgium — as well as BioNTech's German sites are being leveraged for global supply.

Pfizer, BioNTech Vaccine Logistics: Pfizer-BioNTech's vaccine require a storage temperature of negative 70 degrees Celsius to remain effective, thereby necessitating cold-chain logistics.

The companies have developed temperature-controlled thermal shippers utilizing dry ice to maintain the required conditions.

Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across pre-set routes leveraging Pfizer's broad distribution network.

Vaccine Economics, Uptake: The $1.95 billion contracted amount for the initial 100 million doses to be supplied to the U.S. government suggests each dose is priced at $19.50. 

Beyond the initial constrained supply, public willingness will be a key determinant of uptake, BofA Securities analyst Geoff Meacham said in a Wednesday note.

The public is concerned over the incomplete safety profile — an issue likely to prompt a cautious approach, slowing penetration, the analyst said. 

"It is for these reasons, we think, FDA opted to hold an advisory committee (AdCom) December 10th prior to issuing an EUA—allowing public feedback from experts on the VRBPAC to help address and assuage concerns and overall skepticism," he said. 

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

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