Finish Line of Pfizer Eyes Vaccine Race


  • Pfizer, BioNTech release positive early data from Phase 1 trial
  • Will apply for regulatory review by October if tears are successful
  • 7 vaccine candidates from around the world are currently undergoing late stage tests

Last night, US drug maker Pfizer and its German biotechnology partner BioNTech shared positive early data from the Phase 1 study of their COVID-19 vaccine candidate, BNT162, which was released late last month following the Phase 2/3 evaluation. It is one of seven candidates currently undergoing late-stage clinical trials.

The companies said seven days after a second dose, both younger and older adults had higher levels of antibodies than recovered patients, and the vaccine was well tolerated in all populations with mild to moderate fever in less than 20% of participants. “Once clinically successful, Pfizer and BioNTech are on track to seek regular evaluation of BNT162b2 since October 2020, and once regulatory approval is obtained, they are currently planning to deliver up to 100 million doses worldwide by 2020 and about 1.3 billion doses by the end of 2021, “the press release said. The U.S. government placed an initial order of 100 million doses for $ 1.95 billion and could receive a maximum of 500 million additional doses.

Source: Society for Regulatory Professionals.

Meanwhile, Johnson & Johnson confirmed yesterday that it is the largest Phase 3 study plan of a COVID-19 vaccine we have yet to see. It is submitting 60,000 people around the world for the trial of the late stage which is expected to start in early September. The Phase 1/2a clinical trial began last month.

If a fax machine becomes available this year because many investors remain optimistic, then the next challenge for leaders will convince people to receive it. This is one reason why scientists need to make sure that side effects are tolerable. 35% or one in three Americans would not receive a free, FDA-approved vaccine if it were ready today, according to a Gallup poll conducted between July 20-August 2. Australian Prime Minister Scott Morrison said on Wednesday that he would “expect it to be as obligatory as you might make it” with few exceptions and was forced to track down the same day because of the backlog.

In the midst of all the health updates, history is often comforting, as it is a reminder that we are not alone and the world is facing pandemics, recurring waves of new cases, strict social distancing rules, business closures, economic activity declining, and even wear mask for. We are not the first to experience these strange circumstances, and we will probably not be the last.