Pfizer and BioNTech shares rose sharply on Monday by 4% and 10%, respectively. This happened after the US Food and Drug Administration (FDA) assigned an “accelerated” status to their two COVID-19 potential vaccines.
Although the companies have not yet completed the final tests and have not received approval for the production and sale of their vaccine, the status gives them a chance to accelerate the transition to these stages. It also gives a chance that their vaccine will receive a FDA “priority review” status, which means that management can decide on approval within six months.
In early July, they said that phase 2 of clinical trials of a vaccine BNT162b1 showed that all 24 volunteers who received two injections had a “strong immune response” to the virus. It was even stronger than that patients who underwent COVID-19 had.
While data on these trials is due to be released this month, today Pfizer and BioNTech intend to move on to testing the most promising of the potential vaccines with up to 30,000 participants in the United States and Europe.
“The FDA’s decision to grant these two COVID-19 vaccines an ‘accelerated status’ is an important milestone in efforts to develop a safe and effective SARS-CoV-2 vaccine,” said Peter Honig, Pfizer’s Senior Vice President of global regulation. “We look forward to continuing to work closely with the FDA throughout the clinical development of this Project Lightspeed program to evaluate the safety and efficiency of these vaccines.”
According to Pfizer, if regulators eventually approve the drug, Pfizer and BioNTech will deliver up to 100 million doses by the end of the year and at least another 1.2 billion by the end of 2021.
Moderna which is developing a potential vaccine using technology similar to Pfizer and BioNTech received the same “accelerated” status in May for its COVID-19 vaccine candidate.
Moderna shares jumped 14.65% on Monday because of the news that they will be added to the Nasdaq-100 index before the market opens on July 20.
Analysts estimate the potential annual revenue from global COVID-19 vaccine sales at $5 to $10 billion.
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