- Pfizer and BioNotech said their late-stage trial is proceeding as planned and they hope to include 30,000 participants by next week.
- The two companies announced on Saturday that they had submitted a proposal to the FDA to expand phase-three testing of their coronavirus vaccine to include 44,000 participants.
- The expansion will help companies ensure that their test participants reflect diverse populations, particularly in relation to people with underlying health conditions.
Pfizer and German biotech firm BioNTech announced on Saturday that they have submitted a proposal to the US Food and Drug Administration to expand the phase-three trial of their coronavirus vaccine to include 44,000 participants, with a cost of 30,000 A significant increase from the previous goal.
The companies developing the vaccine together said in a statement that the trial is proceeding as planned and they are expected to include 30,000 participants by next week.
“The proposed expansion will help companies further increase test population diversity, and include people as young as 16 years of age and with chronic, stable HIV (human immunodeficiency virus), hepatitis C or hepatitis B infection.” Must also provide. Additional safety and efficacy data, “the companies said.
Representatives from the Food and Drug Administration and the Department of Health and Human Services did not immediately return CNBC’s request for comment.
Public health experts have emphasized the need for participants in vaccine trials, reflecting a diverse population, including the elderly, communities of color, and people with underlying health conditions, all of whom have been inconsistently affected by the virus. . Involving diverse participants helps ensure that the vaccine candidate is truly safe and effective in a wide variety of populations.
Modern, another company developing the Kovad-19 vaccine, told CNBC earlier this month that they were slowing enrollment in its trial a bit to ensure that minorities are adequately represented at risk of the disease .
Pfizer CEO Albert Borla said earlier this month that the pharmaceutical company could deliver its late-stage trial results as soon as October. On Saturday, the companies reiterated the possibility that they may have data indicating whether the vaccine is effective by the end of October. However, it may take longer to gather enough data to determine whether the vaccine is safe, as it will take months to determine what side effects, if any, the vaccine may cause.
The companies stated, “The decisive test is event-based and there are many variables that will ultimately affect read-out timing.” “As previously stated, based on the current transition rate, companies expect a decisive readout on efficacy by the end of October.”
Through Operation Taunting Momentum, the Trump administration quickly attempted to market a Kovid-19 vaccine and therapeutic, with the US now investing more than $ 10 billion in six candidates, including Pfizer. The US announced in July that it agreed to pay approximately $ 2 billion to Pfizer and BioNotech for at least 100 million doses.
In July, Pfizer announced that an early-stage clinical trial showed that the vaccine produced some neutralizing antibodies, which researchers believe is necessary to build immunity from the virus.
-CNBC’s Meg Tirrell Contributed to this report.
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