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On Monday before the stock market opened, Pfizer announced that its COVID-19 mRNA vaccine had proven 90% effective so far in its ongoing late-stage trial, lifting the company’s shares nearly 8% through the course of the day...The same day, in a stock sale Pfizer says was planned months ago, CEO Albert Bourla offloaded 132,508 shares—more than 60% of his total holdings—for $5.6 million...Insider trading? Nope. Extraordinarily lucky? To be sure. And no doubt the size and timing of this sale, coupled with Bourla's confidence over the last few months leading to Monday's data announcement, are enough to rile up critics of executive pay packages in Big Pharma...READ MORE

Pfizer announced positive early results from its coronavirus vaccine trial, cementing the lead in a frenzied global race that has unfolded at record-breaking speed...Pfizer, which developed the vaccine with the German drugmaker BioNTech, released only sparse details from its clinical trial, based on the first formal review of the data by an outside panel of experts...The company said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles. No serious safety concerns have been observed, the company said...READ MORE

Deaths after flu vaccination keep rising in South Korea. But as local health authorities work to calm concerned citizens by refuting a connection between the two, a fellow Asian country has taken the precautionary measure of suspending two shots given to people who later died...Singapore has temporarily pulled its backing for SK Bioscience’s SKYCellflu Quadrivalent and Sanofi Pasteur’s VaxigripTetra, the Ministry of Health said...READ MORE

The Trump administration announced it will cover a vaccine for COVID-19 at no cost to Medicare beneficiaries...The Centers for Medicare & Medicaid Services released an interim rule on Wednesday that aims to remove regulatory barriers for seniors to get the vaccine, which is expected to be approved by early next year...READ MORE

A senior U.S. government official complained...that the World Health Organization has not shared enough information about its planned mission to China to investigate the animal origins of the coronavirus...Garrett Grisby of the U.S. Department of Health and Human Services griped that the criteria for WHO’s China mission had not been shared with other nations. He spoke during a weeklong meeting of the U.H. health agency’s member countries...“The (terms of reference) were not negotiated in a transparent way with all WHO member states,” he said via video conference, referring to the mission’s criteria. “Understanding the origins of COVID-19 through a transparent and inclusive investigation is what must be done.”...READ MORE

...the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody...Although the FDA has previously issued EUAs to more than 50 antibody tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells...READ MORE

Japanese drugmaker Takeda has quickly emerged as one of the leading forces in the fight against COVID-19 as a vaccine manufacturing partner and R&D lead on a convalescent plasma-based therapy. Now, Takeda will help another biotech distribute its potential COVID-19 vaccine in the drugmaker's home country...Moderna has tapped Takeda to bring 50 million doses of its mRNA-based COVID-19 shots to Japanese shores as part of a government-backed vaccine distribution effort...Takeda will import and distribute Moderna's shot, dubbed mRNA-1273, starting in the first half of next year, as well as handle local regulatory approvals...READ MORE

Brazil’s health regulator halted clinical trials of the potential coronavirus vaccine CoronaVac, citing an “adverse, serious event,” according to a statement it posted to its website Monday night...The potential vaccine is being developed by Chinese biopharmaceutical firm Sinovac and in Brazil would be mostly produced by Sao Paulo’s state-run Butantan Institute. Butantan said in a statement that it was surprised by Anvisa’s decision and that it would hold a news conference Tuesday...The CoronaVac shot has stirred controversy in Brazil, where President Jair Bolsonaro has cast doubt on its prospective effectiveness. He sparked confusion last month when he publicly rejected it, saying Brazilians would not be used as guinea pigs. The declaration followed news that his health minister, Eduardo Pazuello, had agreed to purchase CoronaVac doses produced locally by Butantan...READ MORE

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies. The list will provide a basis for bolstering biopharmaceutical production at home of essential medicines and medical products and for addressing supply chain vulnerabilities...READ MORE

Washington, Oregon and Nevada will join California to independently review any coronavirus vaccine before distributing it to the public...Gov. Gavin Newsom said Tuesday that the three states would identify their own public health experts to participate in the scientific review committee he announced last week, which was charged with ensuring that any vaccine approved by the U.S. Food and Drug Administration is safe and effective...California has also formed a second committee to develop guidelines for the ethical distribution of vaccines, Newsom said, addressing questions about who should receive the first doses and how to allocate potentially limited supplies...READ MORE