Dr. of Fox News. Mark Siegel provides insights into the development of the coronavirus vaccine by companies such as Pfizer and AstraZeneca.
Pfizer and Bioentech are considering increasing their registration for the Phase 3 COVID-19 vaccine trial to about 44,000 participants after submitting a proposal to the Food and Drug Administration on Saturday.
According to a press release, the proposed expansion would allow companies to increase the diversity of trial participants, including those under 16 years of age and adolescents, with stable HIV, hepatitis C or hepatitis B infection. Additional safety and effectiveness data.
| Ticker | Security | The last | Change | Change% |
|---|---|---|---|---|
| P.F.E. | PFIZER INC. | 36.07 | +0.42 | + 1.18% |
| BNTX | BIONTECH | 65.13 | +3.93 | + 6.42% |
The companies noted that the trial is expected to reach an initial enrollment target of 30,000 participants by next week.
“We will respond by the end of October on the coronavirus vaccine,” says Pfizer CEO Best-Case Scanario.
Pfizer and Bioentech reiterated that the results of a late-stage trial of their vaccine candidate could be available in early October.
“The main trial is event-based and there are a lot of variables that will ultimately affect read-out time,” Pfizer and Bioentech said. As stated earlier, based on current infection rates, companies continue to expect a definitive reading on efficacy possible by the end of October. “
The federal government announced in July that it had reached a 1.95 billion deal with Pfizer and Bioentech for at least 100 million doses after approval by the FDA. Under the agreement, an additional 500 million doses could be obtained, and US citizens would receive the vaccine free of charge.
The move comes as part of the White House Operation Operation Speed Initiative, which aims to deliver 300 million doses of the safe and effective COVID-19 vaccine by January 2021.
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The announcement comes less than a week after the CEOs of major coronavirus vaccine developers announced a joint pledge to avoid applying for FDA approval, even for emergency use, until safety and efficacy standards are met.
“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which the COVID-19 vaccine is evaluated and ultimately approved,” the companies said in a statement. .
The joint statement noted that the scientific evidence for regulatory approval should be “large, high-quality clinical trials that should be randomized and observer-chaotic, with the expectation of a properly designed study with a significant number of participants in different populations.”
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Candidates for the other two vaccines are on trial in a late-stage trial, one developed by Moderna Inc., and another by AstraZeneca and Oxford University.
| Ticker | Security | The last | Change | Change% |
|---|---|---|---|---|
| AZN | AstraZeneca plc | 53.73 | +0.66 | + 1.24% |
| MRNA | Modern INC. | 59.34 | +1.78 | + 3.09% |
Vaccines for hold Strazeneca and Ox Xford resumed trials on Saturday due to safety concerns. AstraZeneca’s chief executive, Pascal Soriot, said this week that despite the break, the company should know before the end of the year whether its vaccine is effective against candidate COVID-19.
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