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 –
Experts have highlighted the need to support industry sectors dominated by women, as the economic downturn from the pandemic was affecting a disproportionately high number of businesswomen.Women had been left in especially dire straits from the pandemic’s economic impacts, such as reduced work hours and mass layoffs in women-dominated sectors such as textile, tourism and health, according to women entrepreneurship program officer Pertiwi Triwidiahening of United Nations (UN) Women Indonesia.A 2017 report from the International Labour Organization (ILO) shows that women make up 58 percent of employees in Indonesia’s garment, textile and footware industry. In addition to mass layoffs, a UN Women study found that women has seen an increase in unpaid care work, whereas women were already carrying three times the domestic workload of men before the Indonesian outbreak emerged in early March.The coronavirus-induced economic crisis is also affecting women-owned enterprises. According to the April 2020 survey of UN Women’s WeEmpowerAsia program, produced in collaboration with the European Union and UN Women, 86 percent of all women entrepreneurs surveyed said that they had been negatively affected by the health crisis, while 34 percent of respondents said that they might have to permanently close their businesses. The impact has been greater on small and medium enterprises (SMEs), as they had “lower capacity to absorb the shock to the supply chain and customer revenue,” said the UN Women Guidance Note for Action on supporting SMEs toward gender equality in COVID-19 recovery. Women entrepreneurs owned 60 percent of all SMEs in Indonesia, where SMEs accounted for more than half of gross domestic product (GDP), according to production and marketing undersecretary Victoria Simanungkalit of the Cooperatives and Small and Medium Enterprises Ministry.The government has earmarked an SME stimulus fund of Rp 123.46 trillion as part of its economic recovery program, out of which Rp 114.06 trillion is allocated for loan repayment relaxation and loan restructuring. Another Rp 7 trillion is for working capital financing that aims to reach 23 million SMEs and cooperatives that do not have access to financial institutions. Victoria noted, however, that women-owned SMEs had contributed just 9.1 percent to GDP. She added that common issues included business planning and strategies, and that women owners of SMEs needed support through training.“Training is an important aspect. It’s not enough to hold webinars only, it is more important [that they have] mentorship,” she said.Numerous organizations are making efforts to address the specific issues women are facing during the health crisis, like UN Women Indonesia’s WeLearn online training program for women entrepreneurs.Offered in collaboration with consumer goods giant Unilever, WeLearn had over 5,200 registered users as of May 31, according to Pertiwi of UN Women Indonesia.Some women business owners have taken advantage of the free training program, including Vidi Astuti Damayanti of MamaIbu Chicken Wings and Sauce. The 48-year-old homemaker told The Jakarta Post by text message on July 16 that she was able to expand her business by taking part in the WeLearn women entrepreneurs program.“The interactive learning was robust and continuous,” said Vidi, elaborating that she learned the how-tos of business plans and basic accounting, as well as digital marketing and the legal aspects of running her business. She now employs two other female homemakers in keeping with the spirit of women’s empowerment and social entrepreneurship, which she says she learned during the program. Nita Yudi, who chairs the Indonesian Businesswomen Association (IWAPI), said during last Thursday’s webinar that such initiatives were commendable and should be continued, but stressed that additional support programs were still needed. “The provision of WiFi or free internet [access] is necessary because right now, everything is done [online],” Nita suggested as a form of government support, pointing out that internet access was uneven between regions in the country, despite the facility’s vital importance during the health crisis.Topics : “If businesses do not support women during this time, then when the economy restarts, companies risk losing their women workers or workers becoming less productive as a result of dealing with [their own] difficulties during the crisis,” Pertiwi said in a webinar on July 16.The government estimates that some 5.5 million people may lose their jobs this year due to the economic crisis spawned by the public health crisis.According to a report from the Indonesian Hotel and Restaurant Association (PHRI) on July 14, tourism had lost Rp 85 trillion (US$5.87 billion) in total revenue with more than 95 percent of the industry’s workers furloughed without pay.Meanwhile, the latest Bank Indonesia (BI) survey shows that all manufacturing businesses tumbled in the second quarter of the year, with the deepest contraction recorded in the textile industry.