Overnight Health Care — Presented by Gilead Sciences — J&J vaccine pause raises questions, concerns

View in Browser   Presented by Gilead Sciences   Welcome to Tuesday's Overnight Health Care. The phrase of the day: an abundance of caution.  If you have any tips, email us at nweixel@thehill.com, psullivan@thehill.com and jcoleman@thehill.com. Follow us on Twitter at @NateWeixel, @PeterSullivan4, and @JustineColeman8  Today: Federal regulators asked for a pause on administering Johnson & Johnson's COVID-19 vaccine. But the Biden administration insists that the pause will be relatively short and will not have a negative impact on the country's vaccination effort.  We'll start with what's stopped: US health officials call for J&J vaccine pause over rare blood clots Injections of Johnson & Johnson's COVID-19 vaccine came to a sudden stop in states and pharmacies across the country after top U.S. health officials on Tuesday called for a pause while they review cases of rare blood clots in people receiving the shots. The officials said they are reviewing six cases of a "rare and severe type of blood clot" out of more than 6.8 million people in the U.S. who have received the Johnson & Johnson vaccine. While the instances were rare, federal and state officials said the moves were made out of an abundance of caution. The pause is intended to give regulators time to analyze the evidence and make sure providers know how to handle the potential side effects.  The standard treatment for blood clots, a drug called heparin, could cause "tremendous harm," for patients who got the vaccine, so doctors need to know to use alternate treatments, said Peter Marks, a top FDA official. What's next: The Centers for Disease Control and Prevention is convening an emergency meeting Wednesday of its vaccine advisory committee. The committee's recommendations to the agency could run the gamut from adding a warning to the label, to recommending certain populations avoid the vaccine. Implications: Depending on how long the pause lasts, the move could have ramifications for the nation's vaccine supply. It could also worsen vaccine hesitancy, which was already a problem as some people refused to be inoculated. Overreaction? Health officials defended the pause, despite there being only six reported cases, because it's important to get notice to providers quickly. Officials also indicated there is a possibility of a common thread between the clotting seen in J&J patients and in those in Europe who have received the AstraZeneca vaccine.  Read more here.     A MESSAGE FROM GILEAD SCIENCES From HIV to viral hepatitis to today's battle with COVID-19, Gilead scientists have been pushing boundaries for over 30 years. So that we can bring tomorrow's life-changing therapies forward today. Learn more       Regulators did not make the J&J decision lightly During an American Medical Association webinar, FDA's top vaccine regulator Peter Marks explained his decision-making. "There was tremendous consideration, very thoughtful dialogue that went behind this pause, everyone knew that there was the potential that we would cause some concern here, and then it could cause a hit, so to speak, to vaccine confidence," Marks said. "On the other hand, the larger concern was, if we made some announcement about this, did not have a pause ... we would really potentially be in a situation where we had not taken the right steps to inform providers and make sure everyone pays attention to this issue."   The White House brought out Dr. Fauci and coordinator Jeff Zients to offer reassurances Anthony Fauci, the government's top infectious disease expert, and Jeff Zients, the White House coordinator for the COVID-19 response, were added to the daily press briefing on Tuesday. Zients argued that the pause would not lead to a major hit to the U.S. vaccination effort.  "Let me start by saying this announcement will not have a significant impact on our vaccination program," he said. "The J&J vaccine makes up less than 5 percent of the more 190 million reported shots in arms in the United States to date." There are 28 million doses of the other two vaccines, from Pfizer and Moderna, going out this week.  "We have more than enough supply of Pfizer and Moderna vaccines to continue the current pace of about 3 million shots per day," Zients said.  Separately, President Biden also weighed in: "My message to the American people on the vaccine is, I told y'all I made sure we have 600 million doses" of the mRNA vaccines from Moderna and Pfizer, Biden said in the Oval Office. "There is enough vaccine, that is basically 100 percent unquestionable, for every single solitary American," Biden added. Read more here.   Hesitancy concerns: Both Zients and Fauci sought to argue that the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) taking the action that they did showed that the system is working and safety checks are in place.  "The fact that a pause was done, I think is just a testimony to how seriously we take safety and why we have an FDA and a CDC that looks at this very carefully and hopefully will resolve it within days to weeks," Fauci said. "I think it's a very strong argument for safety actually." Read more here.    Want more? Here are 5 questions raised by the J&J vaccine pause     A MESSAGE FROM GILEAD SCIENCES From HIV to viral hepatitis to today's battle with COVID-19, Gilead scientists have been pushing boundaries for over 30 years. So that we can bring tomorrow's life-changing therapies forward today. Learn more     Good news for Moderna: COVID-19 vaccine 90 percent effective six months after second dose Moderna announced on Tuesday that its coronavirus vaccine was 90 percent effective six months after a person receives their second dose. Among participants in its third phase study, Moderna said more than 900 COVID-19 cases were identified, including more than 100 severe cases.   "Vaccine efficacy starting two weeks following the second dose and based on the updated adjudicated cases remains consistent with prior updates, including greater than 90% against all cases of COVID-19, and greater than 95% against severe cases of COVID-19," the company said in a release.  What's next: Moderna wants to receive full approval from the Food and Drug Administration (FDA) for its vaccine, as right now it has emergency use authorization. The company is also progressing on its second phase of testing for adolescents in the U.S. and Canada.   "The Moderna team continues to make important progress with our COVID-19 Vaccine," Moderna CEO Stéphane Bancel said. "The new preclinical data on our variant-specific vaccine candidates give us confidence that we can proactively address emerging variants." Read more here.   FDA ends restrictions on mailing abortion pills during pandemic The FDA lifted restrictions on mailing abortion pills during the pandemic, after the Trump administration moved to keep the decades-old requirement for in-person pickup of the drug during the coronavirus public health emergency. Acting FDA Commissioner Janet Woodcock sent a letter to the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine, informing the groups that the FDA determined that providing the pill remotely through telemedicine and mail did not escalate the risks.  The American Civil Liberties Union (ACLU) had filed a lawsuit against the Trump administration for its decision to enforce the in-person pickup mandate for mifepristone, while suspending the same requirements for other drugs during the pandemic.  The Supreme Court decided the administration could enforce the requirements for mifepristone, a drug used to end early pregnancies and to treat pregnancy losses.   Restrictions lifted only for pandemic: The decision from Biden's FDA only addresses whether the in-person mandate to pick up mifepristone could be enforced during the public health emergency and did not say what will be done after the pandemic.  What's next: Advocates are calling for FDA to end the regulations permanently with ACLU senior legislative counsel Georgeanne Usova saying "We cannot stop here: the restrictions on medication abortion are outdated and have obstructed patients' access for far too long." Read more here.    What we're reading What you should do if you've received the Johnson & Johnson coronavirus vaccine (Washington Post)  Why would a Covid vaccine cause rare blood clots? Researchers have found clues (Stat News) J&J vaccine and blood clots: the risks, if any, are very low (New York Times)     State by state Wyoming keeps two remaining COVID-19 health orders in place (Casper Star Tribune) 4 California counties reopen further, rest of state holds steady amid low COVID-19 rates (Sacramento Bee)  After YouTube pulls DeSantis video for mask fallacies, governor holds another COVID-19 talk with same docs (South Florida Sun Sentinel) Florida's FEMA vaccination roll-out failed Black communities. Except in one place (Miami Herald)   Op-eds in The Hill COVID relief money: States need public-private partnerships Do college campuses still need COVID-19 surveillance testing? Will COVID-19 leave us with a long-term mental health crisis?         Did a friend forward you this email? 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