WASHINGTON — Pfizer announced on Wednesday that it has reached its initial goal of 30,000 participants for the phase 3 trial of its coronavirus vaccine.
Over the weekend, the drugmaker submitted an "amended protocol" to the U.S. Food and Drug Administration to expand the enrollment for its trial to about 44,000 participants. The company said in a statement that this would help increase the diversity of the trials.
If approved, the new volunteers could include children as young as 16 and people with chronic underlying conditions like stable HIV, Hepatitis C, or Hepatitis B infection, to help provide additional safety and efficacy data.
During a presentation to investors on Tuesday, the company said participants were only showing mild to moderate side effects when given the vaccine or a placebo including fatigue, headache, chills and muscle pain.
Based on the current infection rates, Pfizer said it is expecting to learn if it created an effective vaccine or not by the end of October.
The Pfizer vaccine is one of three vaccine candidates currently in the final testing stage in the U.S. One was created by the National Institutes of Health and manufactured by Moderna Inc. and the other is from AstraZeneca.
The major push to find a safe and efficient COVID-19 vaccine is part of President Donald Trump's Operation Warp Speed program, which is designed to get a vaccine to the American people by early 2021.
The Deputy Chief of Staff for Policy at the Department of Health and Human Services, Paul Mango, said at the end of August that two more "candidate vaccines will go into Phase III clinical trials by the middle of September."
Part of the effort involves manufacturing vaccines before they are even approved for use by the FDA, according to the HHS. When a vaccine is approved by the FDA, it will be able to be distributed to the general public.
On Wednesday, the federal government outlined a sweeping plan to make vaccines for COVID-19 available for free to all Americans. In a report to Congress and an accompanying “playbook” for states and localities, federal health agencies and the Defense Department sketched out complex plans for a vaccination campaign to begin gradually in January or possibly later this year, eventually ramping up to reach any American who wants a shot.
The Pentagon is slated to be involved with the distribution of vaccines, but civilian health workers will be the ones giving shots.
For most people, the new coronavirus causes mild or moderate symptoms like fever, cough and shortness of breath. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.
The CDC says the best way to prevent getting sick or spreading COVID-19 is by washing hands often, avoiding close contact with individuals and wearing face coverings or masks when around others.