Within weeks, the Food and Drug Administration is expected to review safety and efficacy data for what may be the first Covid-19 vaccine in the United States, with hopes of immunizing some Americans soon after.But about a half-dozen states and the District of Columbia have planned an extra layer of scrutiny: committees that would vet any vaccine reviewed by the F.D.A., a step many public health experts and officials deem unnecessary given a federal review process they describe as meticulous.- Advertisement – Throughout the pandemic, Mr. Trump and his administration have been criticized for putting pressure on federal health agencies — including the F.D.A. and the C.D.C. — to ease restrictions and speed approvals for vaccines and unproven treatments, such as hydroxychloroquine.The White House initially opposed F.D.A. guidelines that called for gathering comprehensive safety data before the agency would issue an emergency authorization for a vaccine. (The guidelines would have made it nearly impossible to have one approved before the election.) Then, in early October, the administration relented.Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said the F.D.A.’s transparency and guidelines helped assuage the fears of many public health experts who felt “the White House was putting their thumb on the scale in a very big way.”Now, he said, he was “absolutely confident in the F.D.A. process” and thought the state review committees were “absolutely unnecessary.” This past week, he was named to Mr. Biden’s coronavirus task force. The committees — most of them in states led by Democratic governors — are in part a response to the Trump administration’s handling of the pandemic and concerns that political considerations would influence vaccine approvals.“The people of this country don’t trust this federal government with this vaccine process,” Gov. Andrew Cuomo of New York said in September when announcing his state’s vaccine committee, led by a Nobel-winning virologist. State officials said they did not believe they would slow any vaccinations. They hoped to examine clinical trial data once it became available, conducting their reviews alongside the federal government.It may not even be possible for states to hold up a vaccine. While they have some authority to control how drugs are dispensed within their borders, three former F.D.A. lawyers said that states would not be able to thwart distribution during a pandemic.Besides New York, officials in California, Connecticut, West Virginia and the District of Columbia have appointed committees to review coronavirus vaccines offered for F.D.A. approval. Governors in Nevada, Oregon and Washington have joined California’s effort, with each state adding a representative to the panel.Safety and efficacy data will also be examined by two independent federal advisory committees of medical experts. One panel counsels the F.D.A.; the other offers recommendations to the Centers for Disease Control and Prevention, which sets guidelines and priorities on who should get a vaccine.“It’s an incredibly rigorous and intense process that is evidence- and science-based,” said Dr. Julie Morita, who has served on the C.D.C.’s advisory committee and is an executive vice president at the Robert Wood Johnson Foundation, a public health philanthropy.Dr. Morita said she thought the state committees would ultimately come to the same conclusions as the federal government, but worried about a lack of consistent messaging.“The last thing we need right now is any kind of miscommunication about what the recommendations are,” she said. “The more aligned everybody is, the better for the public.” Dr. Morita is now serving on President-elect Joseph R. Biden Jr.’s Covid-19 task force. The reviews are intended to help persuade a hesitant public to get shots once they are approved, several state officials said in interviews. Recent polls show that between a third and half of Americans would be reluctant to get a coronavirus vaccine.- Advertisement – State officials have said Mr. Trump’s loss in the election will not alter their plans for reviews. Indeed, the first F.D.A. authorizations may fall under Mr. Trump’s watch. Pfizer announced last week that its vaccine, developed with the German company BioNTech, appeared more than 90 percent effective in early data from clinical trials, and Moderna’s vaccine is close behind in the development process.Trust IssuesThe tension between states and the federal government illustrates a heightened politicalization of vaccines and their approvals, a process that is routinely accepted by physicians and public health departments across the country.“This has become a somewhat political conversation,” Dr. Mark Ghaly, California’s health secretary, acknowledged in an interview. He said the state’s review was intended “to give Californians additional confidence and trust in the system.”The state committee, named in October, is still deciding on a process, but it plans to assess some of the same data used by the federal advisory committees, according to Dr. Arthur Reingold, the group’s chairman.Dr. Reingold, head of epidemiology at the University of California, Berkeley School of Public Health, served on the C.D.C.’s advisory committee less than two years ago and said he had the “greatest respect” for it.“We have an unusual set of circumstances, and we are trying to respond to those circumstances,” Dr. Reingold said. “At the end of the day, these vaccines will not help us if people do not accept them.” Dr. Reingold said he thought the group would complete its review swiftly, given the experience of its members, some of whom also serve on the C.D.C.’s advisory committee. Pfizer has said it plans to ask the F.D.A. for emergency authorization this month. The application would include two months of follow-up safety data from “Phase 3” trials. Phase 3 marks one of the last steps in the development process, when tens of thousands of volunteers get a vaccine and wait to see if they become infected, compared with others who received a placebo.Those trials are large enough to reveal some rarer side effects or more severe problems that may not have surfaced earlier. By September, Pfizer’s trial had 44,000 participants, and no serious safety concerns have been reported.Once the F.D.A. receives an application for emergency use, it begins a review of the data and sends a summary of the information to its advisory committee, which eventually makes a recommendation to the agency.If the F.D.A. authorizes the vaccine, the C.D.C. advisory group meets to decide how the vaccines should be used and allocated.In interviews, members of several states acknowledged the committees’ expertise, insisting that their own assessments would not be duplicative.Officials in West Virginia and the District of Columbia said their aim was to communicate the safety and effectiveness of a vaccine to the public, not necessarily to approve or deny its use.“We recognize that those institutions have expertise and assets that we don’t have. It’s not to replicate that process,” said Dr. Deidre Gifford, Connecticut’s top public health official and co-chair of its vaccine committee. Dr. Gifford said her group — made up of a dozen doctors and health experts appointed by the governor — would examine the approval process to confirm that it has been typical, or as typical as it could be during a pandemic. “We want shots in arms within 24 hours,” Mr. Mango said at a news briefing last month for Operation Warp Speed, the federal effort to secure a vaccine. “Any delay that the state wants to impose will be a delay in getting its citizens — its most vulnerable citizens — vaccines. We think it is actually counterproductive for them to talk about this.” – Advertisement – But some health officials and experts worry that the state reviews could instead create inconsistency and sow doubt about a crucial tool in stopping the global contagion.Paul Mango, deputy chief of staff for policy at the U.S. Department of Health and Human Services, said state leaders were undermining the expertise of the F.D.A., which he called the “most rigorous organization in the world.” In an effort to address state officials’ concerns, the F.D.A. said last week that it would offer briefings on its vetting process and the basis for any decision to authorize a vaccine.Dr. Peter Marks, director of the F.D.A.’s Center for Biologics Evaluation and Research, which reviews vaccines, said he wanted the process to be transparent and welcomed questions from state officials. He also said he had felt “buffered” by the F.D.A. commissioner, Dr. Stephen Hahn, from any White House interference. He added that F.D.A. physicians and researchers who assessed vaccines were “civil servants” and “not political appointees.” Similarly, in New York, the state committee would work as quickly as possible, said Gareth Rhodes, a member of Mr. Cuomo’s coronavirus task force and special counsel at the Department of Financial Services.The group will gather “whatever information they need to confidently make a recommendation to the Department of Health,” Mr. Rhodes said. That would include reviewing data made public through the C.D.C. and F.D.A. advisory groups, as well as getting information directly from vaccine makers.Mr. Cuomo, speaking with CNN on Friday, said the goal was “to give people confidence,” adding, “As soon as the F.D.A. approves it, we will have our panel approve it.”In an interview with The New York Times, Mr. Cuomo said if his state panel expressed confidence in the vaccine, he would be the first New York resident to receive it and his adult children would be vaccinated on television to reassure the public it was safe.Earlier that day, Mr. Trump attacked New York’s planned review, claiming that the state would not receive vaccines when they are first rolled out across the country.A Rigorous ProcessHealth experts who had been involved in recommending other vaccines said there was little reason for the public to doubt the approval process, which takes into account comprehensive clinical trials conducted by universities and other independent bodies. One of the main goals is to “reassure the public and the governor that it was free of political interference,” she said.Dr. Ezekiel Emanuel, a professor of medical ethics and health policy at the University of Pennsylvania and a member of Mr. Biden’s coronavirus team, described the state reviews as “a symbol of the utter breakdown in trust in the process,” and said he did not think they would reveal anything the federal reviews did not.“From a practical standpoint, it’s probably not going to be that important,” he said. “From a trust standpoint, it may be helpful.”Sheila Kaplan contributed reporting. – Advertisement –
Topics : Jakarta Legal Bureau head Yayan Yuhanah said there were other legal avenues for PT Taman Harapan Indah to challenge the verdict.Read also: Reclamation or not: City struggles to win lawsuits“The plaintiff can file a case review [with the Supreme Court],” Yayan said, “However, I am not yet sure if they will do it.”Anies lauded the Supreme Court’s ruling and expressed his wish to win the other legal battles against reclamation efforts in Jakarta Bay.“The ruling is in line with our regulation. The other legal proceedings [over other reclaimed islets] are still ongoing. Hopefully, we can win those cases too,” he told journalists on Tuesday.The city’s decision to revoke the permits of the developers in charge of the 13 reclaimed islets in 2018 followed an investigation by the Jakarta North Coast Reclamation Management Coordinating Body that found that the projects had failed to follow necessary procedures, including in the submission of design and Environmental Impact Analysis (Amdal) reports. The other islets with revoked permits are islets A, B and E, developed by PT Kapuk Naga Indah; islets I, J and K, developed by city-owned PT Pembangunan Jaya Ancol; islet M, developed by PT Manggala Krida Yudha; islets O and F, developed by PT Jakarta Propertindo; islets P and Q, developed by KEK Marunda Jakarta; and islet I, developed by PT Jaladri Kartika Pakci.Anies did not revoke the permits of the three developers overseeing the reclamation of islets C, D, G and N, arguing that the four islets had already been built on. PT Manggala Krida Yuda challenged the city’s decision in the PTUN, but the court rejected the lawsuit.The PTUN also ruled in favor of PT Agung Dinamika Perkasa and PT Jaladri Kartika Pakci after they brought complaints forward. The Jakarta administration has filed appeals against the decisions, and the legal proceedings are currently ongoing. (ami) The Supreme Court has ruled in favor of the Jakarta administration in its appeal of a lower court’s decision to uphold developer PT Taman Harapan Indah’s permit to reclaim and build on man-made Islet H in Jakarta bay.The dispute was one of a few that centered on the city’s revocation of developers’ permits to reclaim and build on 13 islets, including Islet H, through a gubernatorial decree issued by Jakarta Governor Anies Baswedan in September 2018.PT Taman Harapan Indah challenged the decree in the Jakarta Administrative Court (PTUN). In July of last year, the court ruled in favor of the company, a subsidiary of property developer PT Intiland Development. The city administration subsequently filed an appeal with the Jakarta Administrative High Court (PTTUN). In December 2019, the court ordered Anies to revoke the gubernatorial decree but stopped short of ordering the governor to extend the company’s permit to build Islet H.Both PT Taman Harapan Indah and the Jakarta administration then filed appeals with the Supreme Court to challenge the verdict.The Supreme Court’s ruling, posted on its official website mahkamahagung.go.id on Tuesday, said it “rejected the appeal” from PT Taman Harapan Indah and had ruled in favor of Anies.The court overruled the PTUN and PTTUN and reestablished the gubernatorial decree that revoked the reclamation permits.
Kyle Olson captured the Friday night Karl Kustoms Northern SportMod checkers at Marshalltown Speedway. (Photo by Bruce Badgley, Motorsports Photography) By Joyce Eisele Another first time win at Marshalltown came in the IMCA Sunoco Stock Car feature as Shawn Ritter led the 18-lap event from flag to flag. Ritter weathered several cautions during the race but was never seriously threatened. Steve Meyer, who won the season opener, made great headway to finish as runner-up after starting 14th. MARSHALLTOWN, Iowa (May 3) – Kyle Olson made his first visit to Marshalltown Speedway’s victory lane on Cliff Chambers Memorial Friday night. From there on he remained as captain of the ship, capturing his first win ever at the speedway. Brayton Carter had a good showing as he finished as the runner-up after starting back in 16th. The Karl Kustoms Northern SportMods ran 18 laps and in the end it was Olson weathering the yellow flags to take home the win. Olson started sixth but had command of the race by the time lap three was scored. After a restart for a caution at lap four, Rust took off like a rocket and sailed to the top spot by the time lap five was in the books. From there on, Rust ran away and hid from his competition, and flew under the checkers to take the win. Tim Ward took the runner-up position, getting around Gustin on the final lap. The IMCA Sunoco Hobby Stock main event went flag to flag with David Rieks leading all but that opening lap on his way to victory. Rieks pulled away as the race wound down, leaving Shannon Anderson to finish a distant runner-up. The IMCA Late Models opened up their season at the speedway for 2019 and in their 20-lap main event it was Justin Kay taking all the marbles. Kay jumped to the immediate lead and led all 20 laps to take the easy victory going away. The most interesting battle of the race was between Joel Callahan and Todd Cooney as they fought tooth and nail for position. It was Callahan winning the fight to take second place over Cooney in third. The evening ended with the 20-lap IMCA Modified feature. Ronn Lauritzen started on the outside of the front row and shot to the lead when the race went green. He soon had Jimmy Gustin hot on his tail and Joel Rust was coming fast.