Virus World

An expert panel told federal officials late Monday that AstraZeneca “may have included outdated information” in a press release announcing results from a trial of its COVID-19 vaccine candidate, the NIH said.The drug maker announced Monday in a press release and phone call with reporters that its vaccine candidate demonstrated an overall efficacy of 79% against symptomatic disease from COVID-19 and was completely protective against severe disease or hospitalization.  Anthony S. Fauci, MD, who heads the NIH’s National Institute of Allergy and Infectious Diseases, said he was copied on a “rather harsh note” written by the data and safety monitoring board (DSMB) to AstraZeneca saying that the company had made conclusions about the efficacy data included in the press release that “were somewhat outdated and might in fact be misleading a bit and wanted them to straighten it out.” Around midnight, the NIAID issued a press release that “essentially told the company they better get back with the DSMB and make sure that the correct data get put into a press release,” Fauci said on ABC’s “Good Morning America.” In the release, the NIAID said the DSMB sent notes to the NIAID, the Biomedical Advanced Research and Development Authority and AstraZeneca “[expressing] concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”

“This is really what you call an unforced error,” Fauci said. “The fact is, this is very likely a very good vaccine, and this kind of thing does nothing but really cast some doubt about the vaccines and maybe contribute to hesitancy. If you look at it, the data really are quite good. When they put it into the press release, it wasn’t completely accurate.” The data reported Monday by AstraZeneca were from a trial conducted primarily in the United States. The overall efficacy number was higher than the average efficacy for the vaccine reported from trials in the United Kingdom and Brazil last year. In a statement, AstraZeneca said the newly released data “were based on a prespecified interim analysis with a data cutoff of 17 February.” “We have reviewed the preliminary assessment of the primary analysis, and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis,” the company said. “We will immediately engage with the independent DSMB to share our primary analysis with the most up-to-date efficacy data. We intend to issue results of the primary analysis within 48 hours.” Amesh A. Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security, said he would like to see more information about what the DSMB was referring to.

“Unfortunately, most newspaper headlines are not going to contain the nuance that likely underlies the DSMB concerns, and it will be a challenge to communicate what is occurring to the general public,” Adalja told Healio. “It’s important that the statement does not mention anything about safety but, in my reading, is about the way the data were combined, using older trials, to arrive at an efficacy calculation.” AstraZeneca said Monday that it would submit the vaccine to the FDA for emergency use authorization in the U.S. in the first half of April and would have 50 million doses ready to be shipped in the first month, pending authorization. The company said the DSMB identified no safety concerns in the new trial, including no increased risk for thrombosis or “events characterized by thrombosis” among more than 21,500 people who had received at least one dose of the vaccine. Health officials in Europe also have declared the shot safe after several European countries halted their rollout of the vaccine over reports of blood clots in vaccinees.

The Trump administration is predicting a Covid-19 vaccine could be available in 2021, but Dr. Anthony Fauci said the government can’t force people to take it. While the Trump administration has predicted a Covid-19 vaccine could be available in 2021, it won’t be mandated by the federal government, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “I don’t think you will ever see mandating of a vaccine particularly for the general public. If someone refuses the vaccine in the general public you cannot force someone to take it,” Fauci said on Tuesday in a virtual townhall organized by the website Healthline. A recent Gallup poll found more than a third of Americans are unwilling to get a Covid-19 vaccine. There is no contingency plan to tackle resistance to Covid-19 vaccination in the future, Fauci said, adding that hospitals can implement policies where anyone who is unvaccinated will not be allowed person-to-person contact with patients. Mandatory vaccine requirements generally fall under state health authorities, who can also make recommendations like the yearly flu vaccines.  

It should be clear by the end of 2020 whether some of the Covid-19 vaccines that are currently in phase 3 trials are safe and effective for public usage., The National Institutes of Health announced last month that a vaccine developed by the Boston-based company Moderna had begun the phase 3 trial with 30,000 adult volunteers who had not been infected with Covid-19. A vaccine developed by the pharmaceutical AstraZeneca is also in phase 3 trial. The government, Fauci said, has already pre-ordered the vaccines and made guaranteed purchases. “The good news is that if the vaccines are safe and effective, you have already got a head start in making the doses without wasting anytime.”

Around tens of million doses should be available by early 2021, Fauci added. The Advisory Committee of Immunization Practices, which guides the Centers for Disease Control and Prevention along with a newly formed committee by the National Academy of Medicines, will prioritize who will receive the initial rounds of vaccines. “They will decide who will benefit and need the [vaccines] the most. And that is done independently of the companies and people involved in the trial,” Fauci said. While drugs such as remdesivir and dexamethasone have shown benefits in randomized placebo controlled trials for patients with severe Covid-19 cases the focus is now on treatments for early stages of the infection. “Direct antivirals, monoclonal antibodies, convalescent plasma will likely be given early as they are directed against the virus,” Fauci said. He refused to comment on potential problems that could erupt between the U.S. and other countries, following the news that the U.S. has bought 90% of the global supply of the remdesivir.  Meanwhile, as schools gear up to reopen after summer holidays, Fauci said a big country like the U.S. can’t take a one-dimensional approach. “Places which are in the red zone—where test positivity rate is higher than 10%, must think twice before reopening.” A July 28 article by the New York Times said 21 states in the U.S are presently in the red zone. Fauci asked the public to remain cautious of news of Russia approving a Covid-19 vaccine. “The public needs to understand the distinguishing features between having a vaccine and proving that it is safe and effective,” he said.

Trump’s words represent a remarkable escalation of his hostilities with Fauci less than two days before the presidential election. WASHINGTON — President Trump on Sunday suggested he would fire Anthony Fauci following the presidential election. As a crowd at a Pennsylvania rally chanted “Fire Fauci,” Trump paused and then responded: “Don’t tell anybody, but let me wait until after the election … he’s a nice man, but he’s been wrong on a lot.” Trump’s words represent a remarkable escalation of hostilities less than two days before the presidential election. While the president has feuded with Fauci, the federal government’s top infectious diseases researcher, throughout the Covid-19 pandemic, he has never directly threatened to dismiss him. Fauci, 79, has served as the director of the National Institute of Allergy and Infectious Diseases since 1984. Threatening to dismiss a top government researcher on the eve of a presidential election is likely an unprecedented move in American politics. And while it’s not clear whether Trump can legally dismiss Fauci himself, since Fauci is not a political appointee, the president is certainly empowered to remove him from the White House coronavirus task force. There’s also little doubt that the president or a political appointee in his health department could reassign him, as occurred earlier in 2020 with Rick Bright, a scientist who ran a vaccine development agency until his reassignment in May.

The pledge to dismiss Fauci comes amid a broader effort by the White House and the Trump campaign to dismiss the severity of the ongoing Covid-19 pandemic. The U.S. has recorded roughly 80,000 new cases and nearly 1,000 deaths daily in the past week. Even in the face of the escalating case count and death toll, Trump has continued to insist that the United States is “rounding the turn” in its Covid-19 response. In the wake of his own bout with the disease in early October, Trump has told Americans that they shouldn’t fear the coronavirus, given the availability of new therapeutics and forthcoming vaccines. One of the Covid-19 therapies Trump received is an experimental treatment unavailable to Americans outside the context of a clinical trial. And despite Trump’s insistence that a vaccine approval would likely come before Election Day, no drug company has submitted data to the Food and Drug Administration requesting an emergency vaccine authorization. Joe Biden, the Democratic presidential nominee, has sharply criticized Trump for his continued hostility toward Fauci and his broader skepticism for basic facts spoken by government scientists. Biden has said that if he’s declared the winner, one of his first calls would go to Fauci, asking him to continue his government service. Fauci did not immediately return STAT’s request for comment.