A More Transparent And Trusted Covid Vaccine
I have long expressed concerns regarding the safety, efficacy, manufacturing quality, distribution, and administration of anti-Covid-19 vaccines. Many of these concerns have now been echoed by reporters at STAT, a publication that has become essential reading for all who follow diagnostic, vaccine, and drug development for Covid-19.
The article highlights the loss of public trust in our public health institutions, with 62% of Americans worried the FDA will rush to approve vaccines because of political pressure, without adequate regard for safety and effectiveness. But in addition to highlighting the problem, the authors also point toward a solution: a Pew Research Center study which shows that open access to data and independent review inspires more trust in research findings—findings that in the case of a vaccine study need to be trusted for people to be willing to take the vaccine.
While calling for broader access to information about the design, implementation, and results from the vaccine trials, the authors note that “vaccine manufacturers’ current legal obligations and voluntary commitments often fall short of full transparency.”
I have enormous respect for their original reporting and unbiased, unvarnished journalism. This story of the need for increased transparency regarding vaccine development is a case in point. The article is a must-read overview of some of what the public needs to know regarding vaccine development, what and information has been withheld. Proclamations by the companies that are developing vaccines ethically are an inadequate assurance. If read carefully, these assurances are as full of holes as Swiss cheese.
It is only by shining the light on what is missing and by fully disclosing the data and problems encountered that we may achieve clarity and confidence that vaccines if approved, are safe and gain a true measure of their potential effectiveness.
As news of promising progress on coronavirus vaccines have filled the headlines in recent weeks, labor lawyers say employers have been pressing one question in particular: Once approved, can they require employees to take it?
“Until maybe about a month ago, we hadn’t had many clients asking about it,” said Brett Coburn, a labor and employment partner with Alston & Bird. “We’re starting to see a lot more momentum.”
The news that a coronavirus vaccine could start being distributed within the next few weeks has sent stocks soaring and government officials scrambling to develop plans for the herculean task of distributing it across the country. For employers, many of which have kept workers home for months, it has opened a complex set of legal and practical issues: Can they require employees to take a vaccine? Should they offer incentives instead to encourage compliance? And what should they do if employees resist?
“You’re going to have a lot more people who are lacking comfort about safety” of the vaccine after such a short development timeline, said Coburn. “Add on top of that the political issues that have unfortunately taken over. If someone’s not willing to wear a mask, do you think they’re going to put a shot in their body?” The cold rush: Pfizer’s covid vaccine jump-starts race for special freezers It will likely be months before anyone besides health care and other essential workers have access to the vaccine. On Tuesday, an advisory panel to the Centers for Disease Control and Prevention said health-care workers and long-term care residents and staff should get top priority for the vaccine. In the meantime, employers are waiting for specific guidance from federal agencies such as the U.S. Equal Employment Opportunity Commission (EEOC) and the CDC before setting corporate policies, employment lawyers say. Christine Nazer, an EEOC spokeswoman, said in a statement the EEOC “is actively evaluating how a potential vaccine would interact with employers’ obligations under the Americans with Disabilities Act, Title VII of the Civil Rights Act of 1964, and the other laws the Commission enforces.” An email to the CDC was not immediately returned. “There are so many unknowns, so many unanswered questions,” said Sharon Perley Masling, a partner at Morgan Lewis, who said most of her clients are considering just encouraging the vaccine until there is government guidance. “We’re operating from a bit of a blank slate right now.”
The biggest difference between requiring employees to take a vaccine for the coronavirus compared with the flu or other vaccines — which health-care organizations have long required — is that covid-19 vaccines are expected to first be available under an “emergency use authorization” rather than a full FDA licensure, Masling said. “To the best of my knowledge, the issue of whether an employer can require a vaccine that is still under an emergency use authorization hasn’t arisen before,” she said, adding the EEOC might be “cautious about the guidance it will issue about a vaccine that has not yet received full approval.” Once a coronavirus vaccine receives formal government approval, employment lawyers say it’s more likely to be treated like the flu shot, which can be mandated, even if it’s currently rare outside the health care field. How are you adapting to the new normal? The Washington Post wants to hear from you.
President Trump’s doctors said he has taken an antiviral drug, an antibody cocktail, asteroid, and other supplements. A toxicology expert explains. (Luis Velarde/The Washington Post) But that comes with several important caveats. Employers must abide by any state or local laws, as well as provide “reasonable accommodations” to people with qualified disabilities and to those who have religious objections, as required by the ADA and Title VII, respectively. Under the ADA, vaccination is considered a medical examination that must be “job-related and consistent with business necessity or it’s necessitated by a direct threat,” said Karla Grossenbacher, a labor and employment lawyer with Seyfarth Shaw. Collective bargaining agreements with unionized workforces should also be consulted, employment lawyers said. Some big corporations say they are beginning to prepare, if not necessarily issuing mandates. Ford said Nov. 24 that it ordered a dozen specialty freezers to store Pfizer’s coronavirus vaccine at ultralow temperatures, and would make the vaccine available to employees “on a voluntary basis,” said spokeswoman Kelli Felker. In an email, Tyson Foods spokesman Derek Burleson said the meat processor, which has faced outbreaks in its plants, was working with health care firms including Matrix Medical Network to get employees to access to the vaccine when it becomes available. Burleson said it was too early to say whether it will mandate the vaccine, but its decision “will be in full compliance with federal and state law and with the best interests of our team members in mind.” Target spokeswoman Jenna Reck said in an email that its coronavirus task force is closely monitoring vaccine developments and plans to offer it to employees and customers at its in-store CVS pharmacies once a vaccine is authorized and made available to the public. Reck said she did not have additional details when asked whether a vaccine would be required. For many employers, the big question will be not just whether they can mandate the vaccine but whether employees would be willing to take it. A recent study commissioned by the nonprofit COVID Collaborative found that fewer than half of Black people and 66 percent of Latino people said they would definitely or probably take the vaccine if it was offered free of charge. The survey explored the reasons behind the hesitancy, which included a distrust in government, with some pointing to historical injustices. Employers that plan to mandate a vaccine may face dilemmas in enforcing the rule. “What if it’s not just one or two people who refuse to get it, but it’s a whole bunch? Are you going to fire a material part of your workforce?” Coburn said. While employers may be able to draw some lines about who must get the vaccine — such as those who work directly with customers and those who don’t — implementing a mandate in a piecemeal fashion could prompt some employees to sue for discrimination. “If the repercussion is not across-the-board termination, either you’re going to have a toothless mandate or you’re going to put yourself in a position where you may be picking and choosing,” he said.
Offering employees incentives to get the vaccine may be more effective, some experts say. David Barron, an employment lawyer with Cozen O’Connor, said clients are already looking into how they can use wellness programs to reward employees who take the coronavirus vaccine with gift cards or discounts on health insurance premiums, much as they would with getting a flu shot or following other healthy habits. Opinion: Pay Americans to get the coronavirus vaccine “Most large wellness programs have those mechanisms already in place, so you’re really just piggybacking and adding a covid vaccine in that list,” Barron said. Even small nudges could prompt employees to get the vaccine, said Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law at Georgetown Law School. A global survey he co-authored found that 61.4 percent of employees said they would likely get a covid-19 vaccine if their employer recommended it. Small inducements, in some cases, may prove to be more effective than mandates, Gostin said. Research has shown that forcing employees to sign a form explaining why they don’t want to take a vaccine may significantly increase compliance, he said. “The more you make them jump through hoops — to sign forms, to make statements — the more likely they are to just acquiesce,” he said. “The change is the default, making it harder to say no.”
Source and contributors:
William A. Haseltine https://www.forbes.com/sites/williamhaseltine/2020/11/06/a-more-transparent-and-trusted-covid-vaccine/?sh=7cb4c98c5b65