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Morning Briefing

Summaries of health policy coverage from major news organizations

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Wednesday, Sep 9 2020

Full Issue

Pfizer, BioNTech Vaccine On Track For Mid-October Approval Review: CEO

Calling the experimental vaccine his company is developing with Pfizer "near perfect," BioNTech CEO Ugur Sahin said the pharmaceutical companies could be ready to apply for U.S. approval next month.

Pfizer and BioNTech are confident they can have a vaccine against the novel coronavirus ready for regulatory approval by the middle of October or early November, BioNTech CEO and co-founder Ugur Sahin told CNN Tuesday. "It has an excellent profile and I consider this vaccine ... near perfect, and which has a near perfect profile," Sahin said in an exclusive interview with CNN. (Pleitgen and Otto, 9/8)

Pfizer CEO聽Albert Bourla warned on Tuesday that people who don鈥檛 take the聽Covid-19 vaccine will become a 鈥渨eak link鈥 that allows the coronavirus to spread. Bourla, whose company is in late-stage testing for a potential inoculation, said he understands the public鈥檚 concerns about vaccines, which are being developed in record time. He said Pfizer will only request authorization from the Food and Drug Administration after data shows that its vaccine is safe and effective.聽(Lovelace Jr., 9/8)

The race to develop a safe and effective COVID-19 vaccine is well under way, setting the stage to bring to market the fastest vaccine in history. There are dozens of coronavirus vaccines in development, primarily in the preclinical phase when they are tested on animals. In the U.S., there are seven vaccine candidates that have moved into clinical trials with human participants, including three that have moved into the crucial Phase 3 development phase. (9/8)

Also 鈥

The U.S. Senate will on Wednesday hold a hearing on the development of vaccines aimed at eradicating the coronavirus, amid an escalated political rhetoric regarding the potential effectiveness of a fast-tracked vaccine. As President Trump has promised to expedite treatments against the virus that has killed nearly 190,000 Americans, he has appeared publicly rankled by critics who question his handling of the pandemic and those who are skeptical of the viability of a safe vaccine in such record time. (Wise, 9/9)

White House coronavirus advisor Dr. Anthony Fauci said Tuesday a coronavirus vaccine probably won鈥檛 be ready by the U.S. presidential election even as the Centers for Disease and Prevention asks states to ready distribution facilities by Nov. 1. At a health conference, Fauci said it鈥檚 more likely a vaccine will be ready by 鈥渢he end of the year鈥 as drug companies Moderna and Pfizer race to complete patient enrollment for their late-stage vaccine trials by the end of September.聽 (Lovelace Jr., 9/8)

More on the global vaccine race 鈥

Researchers in Russia聽finished Tuesday the early-stage human trials of a聽second COVID-19聽vaccine candidate, according to a report. According to Reuters, 鈥淪iberia鈥檚 Vector virology institute鈥 wrapped up Phase II, attributing Interfax news agency, which reportedly cited 鈥渨atchdog鈥 Rospotrebnadzor.The vaccine candidate is reportedly a 鈥減eptide-based jab鈥 and began human trials on July 27, involving 100 volunteers, the outlet wrote. (Rivas, 9/8)

Venezuelan President Nicolas Maduro on Tuesday proposed administering a Russian coronavirus vaccine to nearly 15,000 candidates in upcoming legislative elections so that they can campaign safely. Russia in August licensed a COVID-19 vaccine after less than two months of human testing, a move celebrated by Moscow but questioned by some experts who note that only about 10% of clinical trials are successful. (Ellsworth, 9/8)

China鈥檚 CanSino Biologics Inc said on Wednesday that expert opinion on its high-profile coronavirus vaccine candidate should not be followed 鈥渂lindly鈥 without sufficient clinical trial data. (9/9)

Brazil鈥檚 acting Health Minister Eduardo Pazuello said on Tuesday that a COVID-19 vaccine would be rolled out for all Brazilians in January 2021. (9/8)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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