CureVac (CVAC) and EU in advanced talks for 225 million Covid-19 vaccine doses

• CureVac has said its Covid-19 vaccine could be ready for the public by mid-2021

Shares of CureVac NV soared Thursday after the German biotech firm said it was in advanced talks for the supply of at least 225 million doses of a potential Covid-19 vaccine to EU member states.

CureVac said talks with the EC, the European Union’s executive arm, include an option to supply an additional 180 million doses, once the mRNA-based vaccine has proven to be safe and effective against Covid-19, bringing the total to up to 405 million doses.

The EC is also in talks with Johnson & Johnson (JNJ) and France’s Sanofi (SNY) for their vaccines under development. It also reached an agreement last week with AstraZeneca (AZN) to buy at least 300 million doses of its potential Covid-19 vaccine which it is developing with Oxford University.

CureVac (CVAC) is specializing in the messenger RNA technology that is the basis of many of the leading Covid-19 vaccine programs, including Moderna Inc. (MRNA) and BioNTech S.E. (BNTX).

“In the current pandemic, we are very pleased to further strengthen the European Commission’s endeavor to provide rapid access to a safe and effective vaccine against the Covid-19 virus across Europe and beyond,” Franz-Werner Haas, chief executive of CureVac said.

“Assuming positive results from our ongoing clinical trials and approval from the regulatory authorities, we are fully committed to ensure broad access to our vaccine,” he added.

Backed by Microsoft founder and billionaire Bill Gates, CureVac listed on the Nasdaq Stock Market on Aug. 14, raising $213 million.

In July, GlaxoSmithKline PLC (GSK) said it was taking a stake in CureVac, the latest move by a major drugmaker to boost capabilities to fight pandemics. FTSE 100-listed Glaxo said CureVac’s mRNA technology would complement its own capabilities as it inked a deal worth up to £866 million ($1.09 billion).

=BioNTech (BNTX) and Pfizer (PFE) to deliver 600 mln doses of SARS-CoV-2 vaccine candidate

BioNTech (BNTX) and Pfizer (PFE) reach agreement with the US government for up to 600 mln doses of SARS-CoV-2 vaccine candidate

Pfizer and BioNTech today announced the execution of an agreement with the US Department of Health and Human Services and the Department of Defense to meet the U.S. government's Operation Warp Speed program goal to begin delivering 300 mln doses of a vaccine for COVID-19 in 2021. Under the agreement, the US government will receive 100 mln doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from the FDA.

• The US government will pay the companies $1.95 bln upon the receipt of the first 100 mln doses, following FDA authorization or approval. The US government also can acquire up to an additional 500 mln doses.

Americans will receive the vaccine for free, consistent with US government's commitment for free access for COVID-19 vaccines.

The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 mln doses by the end of 2020 and potentially more than 1.3 bln doses by the end of 2021.

=BioNTech (BNTX) and Pfizer (PFE) : first clinical trial of COVID-19 vaccine candidates

BioNTech and Pfizer (PFE) announce regulatory approval from German authority to commence first clinical trial of COVID-19 vaccine candidates

BioNTech and Pfizer have announced that the German regulatory authority the Paul-Ehrlich-Institut has approved the Phase 1/2 clinical trial for BioNTech's BNT162 vaccine program to prevent COVID-19 infection. BioNTech and Pfizer are jointly developing BNT162. The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany, and is part of a global development program. Pfizer and BioNTech will also conduct trials for BNT162 in the US upon regulatory approval, which is expected shortly.

The four vaccine candidates are the first candidates from BioNTech's COVID-19-focused project "Lightspeed", each representing different mRNA formats and target antigens. Two of the four vaccine candidates include a nucleoside modified mRNA, one includes a uridine containing mRNA, and the fourth vaccine candidate utilizes self-amplifying mRNA. Each mRNA format is combined with a lipid nanoparticle formulation. The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized receptor binding domain (RBD) from the spike protein is included in the other two candidates. The RBD-based candidates contain the piece of the spike that is thought to be most important for eliciting antibodies that can inactivate the virus.