Milestones :: Perspectives :: Research
COVID 19 Vaccine Programs Update
Pfizer – Our Science
Greater Clarity on COVID-19 Timelines
An Open Letter from Pfizer Chairman and CEO Albert Bourla
October 16, 2020
As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic. I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine.
There are three key areas where, as with all vaccines, we must demonstrate success in order to seek approval for public use. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards….
…So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.
The timelines above reflect our best estimates of when these important milestones could be achieved. For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.
Dr. Reddy’s and RDIF receive approval to conduct clinical trial for Sputnik V vaccine in India
October 17, 2020
HYDERABAD, India–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, today announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study.
“We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine in India.”
Earlier in September 2020, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India…
Moderna Receives Confirmation of Eligibility for Submission of Marketing Authorization Application to the European Medicines Agency for mRNA Vaccine Against COVID-19 (mRNA-1273)
Confirmation underscores Moderna’s commitment to make its vaccine available in the EU
October 14, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has received written confirmation from the European Medicine Agency (EMA) that mRNA-1273, the Company’s vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure. Confirmation of eligibility was given in response to the submission of a letter of intent enabling Moderna to evaluate the opportunity for submitting a Marketing Authorization Application (MAA) for mRNA-1273 with the EMA. This submission follows positive results from a preclinical viral challenge study and the positive interim analysis of the Phase 1 study of mRNA-1273 in healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine…