HUNT VALLEY, Md. (SBG) — Three major drug companies have now announced vaccine candidates with efficacy of at least 90%. Pfizer and BioNTech announced Friday that they had applied to the Food and Drug Administration for emergency use authorization for their Messenger RNA vaccine against SARS-CoV-2, the virus that causes COVID-19. The FDA’s decision is expected by Dec. 10 and the top science adviser for Operation Warp Speed says if approved, the first doses could roll out as soon as Dec. 11.
Moderna Therapeutics and AstraZeneca also announced vaccine candidates with high efficacy against the virus in late stage trials. Other companies, including Johnson & Johnson, are also developing vaccines against SARS-CoV-2. But as rapidly produced vaccines make the jump from concept to reality, questions abound over how they will be distributed.
Some nations have already rejected the idea of mandatory vaccinations
Much like lockdown mandates and stay-at-home orders that have been issued in the United States from the beginning of the COVID-19 pandemic, compulsory vaccination orders cannot be made by the federal government. Individual states set the laws for vaccination requirements and currently, no state has passed a law requiring a vaccination against SARS-CoV-2. Other nations, including Australia and the United Kingdom, have said that they will not mandate the eventual vaccine, as reported by the BBC.
U.K. Prime Minister Boris Johnson ruled out the notion of mandatory vaccines on Tuesday, saying that wasn’t the type of country he led.
“Let's be clear, there will be no compulsory vaccination,” Johnson said. “That's not the way we do things in this country.” But while Johnson dismissed the idea of legal enforcement of inoculation against the novel virus, he spoke out firmly against anti-vaccination conspiracies.
“We think it's a good idea,” Johnson said of getting vaccinated. “I totally reject the propaganda of the anti-vaxxers - they are wrong. We should be very, very pro-vaccine.”
Legal precedent for vaccination mandates does exist in the U.S., dating back to a 1905 Supreme Court case. Like the orders issued by governors and state health departments regarding lockdowns, state officials could issue orders for vaccinations of every state resident in the interest of public safety. That power by state governments is defined by the Constitution. The New York State Bar unanimously passed a resolution earlier this month recommending the state mandate COVID-19 vaccination if voluntary vaccination falls short.
But legal and public health expert Joanne Rosen of the Johns Hopkins Bloomberg School of Public Health said mandates ordered by state governments could shake the public trust in the vaccine. Current state mandates for vaccinations of school children carry exemptions for religious and personal beliefs in many states. Those exemptions, Rosen said, “was kind of like a safety valve to let some of the pressure out of the system so that people could feel that they had some choice.”
“There's a very strong culture in this country and others of personal autonomy and not wanting the government to force you to do something or tell you what to do,” Rosen said on the Public Health on Call podcast. Achieving the overall goal of vaccinating as many people as possible might best be achieved through allowing those personal freedoms, she said.
“Although it seems counterintuitive, providing some opt-out mechanism in fact can protect the overall integrity and legitimacy of the vaccine regime and public health," Rosen said. "Yes, the goal of public health is to ensure that as many people as possible are vaccinated to prevent further transmission of disease. This leaves the question of ‘How best do we achieve that goal?’ A vaccine mandate looks like it's the most straightforward way to do it," she continued. "But, if we have a lot of backlash and resistance to it, how do we then bring those folks onside?”
Executive Director of The International Vaccine Access Center at The Johns Hopkins Bloomberg School of Public Health, Dr. William Moss, told Sinclair that reaching the most vulnerable population with the first doses of a COVID-19 vaccine could be difficult.
“We have a strong system for getting vaccines to children, but we don't have a strong or robust system for getting vaccines to older adults with underlying conditions,” he said. “Those are going to be the groups that are high priority for the vaccine and figuring out how to deliver vaccines to those groups, particularly when we have a prioritization, is going to be very challenging.”
Private companies can mandate vaccines for customers and employees, but that may not be popular
In the absence of government-issued vaccination mandates, private corporations and businesses can issue their own requirements that could apply to their employees or anyone that wishes to interact with them. But verifying proof of vaccination could be difficult.
Following positive news of vaccinations against COVID-19 infection, Chief Executive for Australian airline Qantas Alan Joyce suggested that travelers to certain parts of the world should show proof of vaccination. He suggested that they have a “vaccine passport” that could electronically verify their inoculation.
Employers that wish to compel their employees to be vaccinated face few legal obstacles, experts say.
“Employers have significantly more freedom when it’s an employer just enacting its own policy, and it’s not a government-mandated policy — because constitutional restrictions simply do not apply to private employers,” Baruch College’s Zicklin School of Business law professor Debbie Kaminer told Business Insider. Rutgers Law School professor Sahar Aziz concurred.
“Legally, it will be difficult for you to refuse to take it, and still be able to go to work to that particular job,” she said.
But recent polling from Gallup shows that only 58% of Americans would be willing to take the vaccine, and 42% would not be willing. Those who would refuse the vaccine, the poll shows, cited that the speed at which it was created – less than a year since the first reported case of COVID-19 – rattled their confidence in the product.
Despite the high number of the COVID-19 vaccination skeptics, however, the news of late-stage trial success from Pfizer and Moderna appeared to buoy confidence in the vaccine since the same poll given was in September. Each category, demographic, and region showed a rise in support for taking the vaccine when it becomes available.
Distribution requires careful storage and transportation. That could be difficult and expensive
The vaccine developed by BioNTech and produced by Pfizer requires transportation and storage in ultra-cold temperatures. The Moderna vaccine, developed by Vanderbilt University, can be stored at normal refrigeration temperatures but only for 30 days. AstraZeneca claims that its vaccine, developed by Oxford University, does not require the same ultra-cold storage at any stage.
But it is not yet clear which vaccines will be available and where they will be delivered, once approved and manufactured. Ultra-cold storage has some health care officials scrambling to secure large quantities of dry ice and other low-temperature storage containers. While the U.S. government has said that no one will be charged for a vaccine that they purchase, administrators can charge to give the doses and in the cases of those needing massive quantities of specialized storage, the cost could be high.
For the uninsured and for those that have private health insurance that would not cover the administrative cost of the vaccine, the out-of-pocket cost could present another hurdle for Americans.
Concern has also been raised about getting vaccines safely to Native American tribal communities, some of which over vast areas of remote wilderness. Some tribal leaders have already been forced to choose which government agency would allocate funding of vaccines for their communities, blinding them to the potential fallout of one agency’s ultimate efficiency over another, according to NBC News.
"A big concern is that you make the wrong decision, and you choose the state, or you choose IHS (Indian Health Service) and then one of those doesn't go according to plan and you have no vaccines," said Meredith Raimondi, the director of communications at the National Council of Urban Indian Health. "I mean, it's a gamble at this point."
Timothy Nuvangyaoma, chairman of the Hopi Tribe, told NBC News that his initial relief over news of the vaccines quickly shifted into concern. The Hopi, he said, frequently live in remote areas and just one-third have reliable access to transportation. Residents are scattered over an area that covers more than 1 million acres and reliable electricity, necessary for prolonged cold storage, is rare.
Convincing the Hopi to take the vaccine, is another matter of concern, Nuyangyaoma said.
“There’s always that reluctance as a Native American,” he said. “I have to make sure that it’s going to be able to help. And I don’t want to get people’s hopes up.” American Indian and Native Alaskans have seen a rate of COVID-19 infection that is 3.5 times greater than that of non-Hispanic whites, according to the Centers for Disease Control and Prevention.