Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations.

Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.

CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA) in clinical trials, has received notification from the German Federal Ministry of Education and Research (BMBF) that CureVac is expected receive up to 252 million euros to support the development of its COVID-19 vaccine candidate.

Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced that the inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences (Sinovac LS), or "CoronaVac," shows good safety and immunogenicity on healthy adults aged 60 and above from its phase I/II clinical studies conducted in China, which is comparable to the result in healthy adults aged from 18 to 59 in the earlier studies.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. In a non-human primate preclinical study, immunization with the BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate, protected rhesus macaques against SARS-CoV-2 infection.

As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.

The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech (NASDAQ: BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), known as MSD outside the United States and Canada, Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc. (Nasdaq: NVAX), Pfizer Inc. (NYSE: PFE), and Sanofi (NASDAQ: SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.