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Pfizer proposes expansion of late-stage coronavirus vaccine trial

Pfizer’s world headquarters are located in Midtown Manhattan in New York City.

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Pfizer and German biotech company BioNTech announced Saturday that they have submitted a proposal to the U.S. Food and Drug Administration to expand the phase three trial of its coronavirus vaccine to include up to 44,000 participants, a significant increase from the previous one. goal of 30,000.

The companies, which are developing the vaccine together, said in a statement that the trial is progressing as planned and expect to have enrolled 30,000 participants by next week.

“The proposed expansion would allow companies to further increase the diversity of the experimental population and include adolescents of 1

6 years of age and people with chronic and stable HIV (human immunodeficiency virus), hepatitis C or hepatitis B infection, as well as providing more data on safety and efficacy, “the companies said.

Representatives from the Food and Drug Administration and the Department of Health and Human Services did not immediately respond to CNBC’s request for comment.

Public health specialists stressed the need for vaccine trial participants to reflect a diverse population, including the elderly, communities of color and people with underlying health conditions, all of whom have been disproportionately affected by the virus. The inclusion of different participants helps ensure that the vaccine candidate is truly safe and effective in a variety of populations.

Moderna, another company developing a Covid-19 vaccine, told CNBC earlier this month that they were slowing enrollment in its study slightly to ensure it had sufficient representation of the minorities most at risk for the disease.

Pfizer chief executive Albert Bourla said earlier this month that the pharmaceutical company could have the results of its study late in the day as early as October. On Saturday, the companies reiterated the possibility of having data reflecting the vaccine’s effectiveness or otherwise by the end of October. However, it may take longer to collect enough data to determine if the vaccine is safe, because it will take months of follow-up work to determine what type of side effects, if any, the vaccine may cause.

“The fundamental process is event-based and there are many variables that will ultimately impact reading times,” the companies said. “As stated earlier, based on current infection rates, companies continue to expect a conclusive reading on effectiveness is likely by the end of October.”

Through Operation Warp Speed, the Trump administration’s effort to quickly bring a Covid-19 vaccine and therapies to market, the United States has now invested more than $ 10 billion in six candidates, including Pfizer. The United States announced in July that it agreed to pay nearly $ 2 billion to Pfizer and BioNTech for at least 100 million doses.

In July, Pfizer announced that early-stage clinical trials showed the vaccine produced some neutralizing antibodies, which the researchers believe are necessary to build immunity to the virus.

—CNBC’s Meg Tirrell contributed to this report.

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