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Pfizer expands enrollment for phase three trial to increase diversity of age groups and conditions

PHOTO CREDITS: KENA BETANCUR/AGENCE FRANCE-PRESSE

According to CNBC, Pfizer has expanded the enrollment for its phase three trial from an initial target of 30,000 to up to 44,000 volunteers, so as to increase the diversity in the trial.

Pfizer’s late-stage coronavirus vaccine trial has enrolled more than 42,000 volunteers, the American pharmaceutical company announced when it released a mixed third-quarter earnings report. Pfizer has been teaming up with BioNTech, a German biotechnology company, for developing the experimental COVID-19 vaccine. This announcement came after Pfizer announced early last week that its COVID-19 vaccine is reporting 90% effective based on its early and incomplete test results. 

The company stated that around 36,000 of the volunteers have already taken the second of its two-dose COVID-19 vaccine. The enrollment for its phase three trial was expanded by Pfizer from the initial target of 30,000 volunteers to up to 44,000 volunteers. According to CNBC, the company said that the expansion would allow it to further increase diversity among the volunteers in the trial, and to include adolescents as young as 16 years old and people with pre-existing medical conditions. The vaccine is known to contain genetic material called messenger RNA or mRNA, which scientists expect to trigger the immune system to fight the virus. The phase three trials are considered to be the last crucial step required, in order to get the vaccines clear for distribution.

According to The Associated Press last Monday, Pfizer Inc. has claimed to have developed and tested a COVID-19 vaccine that is 90% effective based on early and incomplete test results. 

Pfizer, which is developing the vaccine with its German partner BioNTech, now is on track to apply later this month for emergency-use approval from the U.S. Food and Drug Administration, once it has the necessary safety information. “We’re in a position potentially to be able to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice president of clinical development, told The Associated Press. “We’re very encouraged.”

Dr. Anthony Fauci, the U.S. government’s top infectious-disease expert, said the results suggesting 90% effectiveness are “just extraordinary,” adding: “Not very many people expected it would be as high as that.” Fauci also added, “It’s going to have a major impact on everything we do with respect to COVID,” as Pfizer appeared to take the lead in the global race by pharmaceutical companies and various countries to develop a well-tested vaccine against the virus. 

Dr. Bruce Aylward, the World Health Organization’s senior adviser, also commented, saying Pfizer’s vaccine could “fundamentally change the direction of this crisis” by March when the U.N. agency hopes to start vaccinating high-risk groups. 

Despite the rejoice, there are still a few drawbacks to the vaccine. Even if all goes well, authorities have stressed it is unlikely any vaccine will arrive much before the end of the year, and the limited initial supplies will be rationed. Also, an interim analysis from an independent data monitoring board is set to determine whether the vaccination trial was successful or not. Dr. Jesse Goodman of Georgetown University, former chief of the FDA’s vaccine division, called the partial results “extremely promising” but ticked off many questions still to be answered, including how long the vaccine’s effects last and whether it protects older people as well as younger ones.

President Donald Trump, who had suggested repeatedly during the presidential campaign that a vaccine could be ready by Election Day, tweeted: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” Additionally, despite early reluctance to join the Trump administration’s Operation Warp Speed, Pfizer signed a contract in July to supply the U.S. with 100 million doses for $1.95 billion, assuming the vaccine is cleared by the FDA. Pfizer has estimated it could have 50 million doses available globally by the end of 2020, enough for 25 million people.

ARTICLE: LIDIYA SHILU

SCIENCE/HEALTH EDITOR: KYLE SMITH

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