The pressure to develop a coronavirus vaccine is growing every day, but it will take time for a safe vaccine to hit the market.
An open letter from the vaccine manufacturer COVID-19, published on Friday, ends any expectations about the availability of the vaccine before election day.
In a letter to the CEO of Pfizer Inc. Albert Burley says that the first time a company can apply for a permit for its vaccine against COVID-19 is the third week of November.
The CEO of another favorite, Moderna CEO Stefan Bansel, told a biotech conference on September 30 that he would not have enough safety data to apply for permission from the Food and Drug Administration by November 25.
Two other candidates for the COVID-19 vaccine in the final stages of clinical trials in the United States, Johnson & Johnson and AstraZeneca, have both been suspended because of possible side effects.
This means that there is currently no chance of approving any vaccine against COVID-19 before the November 3 presidential election.
The news has raised concerns in the public health sector for months that the vaccine could be missed to secure a political victory for President Donald Trump. Over the past six months, he has repeatedly stated that he expected the COVID-19 vaccine to be available before the election.
That changed on October 6, when the White House adopted guidelines published by the Food and Drug Administration that would likely delay the approval of a coronavirus vaccine by requiring drug manufacturers to conduct research for two months before seeking approval.
After this change, the only way the vaccine could appear before November 3 would be if everything went well in the longest-running Pfizer vaccine trials.
Deadlines would be tight. Pfizer requires two doses at 28-day intervals, and on July 27, it began its phase 3 trials in the United States. The second footage would begin on August 24. Two months of follow-up after this second intervention were on 23 October.
It is clear from Burla’s letter that this will take more time. Based on the company’s current trial period and dosing rate, “we expect to reach this limit in the third week of November,” he wrote.
The company is “working at the speed of science,” and security is the number one priority, he said.
Even then, there will be several important stages of safety and surveillance even after the company applies for an emergency vaccine permit.
“All the data contained in our application to the United States will be considered not only by our own FDA scientists, but also by an external group of independent experts at a public meeting convened by the agency,” he said.
The news is an important step in restoring public confidence and confidence in the vaccine evaluation and approval process, said Dr. Kelly Moore, deputy director of immunization and the Immunization Coalition.
According to a survey conducted by Informa Pharma Intelligence, a business intelligence provider and research firm YouGov, 35% of Americans do not believe how fast clinical trials of the COVID-19 vaccine are moving, and 23% say they do not think pharmaceutical companies take into account the best interests of consumers. .
It will also provide space for state and local planners of COVID-19 vaccination programs, who are rushing to prepare for the day of vaccine or vaccines. Having a national distribution infrastructure ready for uninterrupted implementation over the next three weeks would be almost impossible.
“This part of the specifics regarding the actual timing of vaccine approvals will give states the time they need to prepare for a better start to the national vaccination program,” she said.
Contact Elizabeth Weiss at email@example.com
Many people are needed to develop a vaccine against COVID-19. Volunteers can be one of the most important.
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