WASHINGTON — Government health officials are increasingly concerned that by vaccinating nursing home residents first against COVID-19, any health issues that develop afterward will automatically be attributed to the vaccine, potentially worrying an already skeptical public.
Nursing home residents were not included in the clinical trials for Pfizer’s coronavirus vaccine, the first one heading for emergency approval from the Food and Drug Administration. Distribution could begin as early as this weekend.
Concerns raised by independent experts at recent public hearings, questioning whether enough data was collected on vulnerable populations, have drawn the attention of top officials at the Centers for Disease Control and Prevention, the agency that will be primarily responsible with tracking the safety and effectiveness of vaccines once they reach the public.
The officials and experts are worried over the lack of data on particularly vulnerable populations, including immunocompromised individuals and cancer patients, all of whom were excluded from Pfizer’s advanced trial.
With vaccine hesitancy already widespread among Americans, concerns persist over any adverse events that may arise once the distribution phase begins.
“I have a long list of concerns,” said Dr. William Schaffner, an infectious diseases expert at Vanderbilt University Medical Center who previously worked at the CDC. “After all, we’ve got a new virus, a new vaccine using new technologies, and we want to create the largest immunization program this country – maybe the world – has ever seen.”
“There are lots of things that could be construed as bumps in the road,” he continued. “There will be lots of them.”
The CDC’s Advisory Committee for Immunization Practices (ACIP), which provides independent assessments on vaccine allocation to the agency, met on Dec. 1 and voted to recommend that nursing home residents and frontline workers receive the medicine first. Only one panel member voted against the recommendation, raising concerns over the risks of placing nursing home residents within this first group.
The dissenter, Dr. Helen Keipp Talbot, questioned the lack of data from the clinical trials, given that roughly one in ten nursing home residents have a cancer diagnosis and a greater number are otherwise immunocompromised.
But she also questioned whether public confidence will be shaken if the first vaccine recipients – elderly, frail nursing home residents – get ill or die shortly after receiving the medicine, even if the vaccine was not the cause.
“It is a very, very, very real concern,” one CDC official acknowledged to McClatchy, speaking on the condition of anonymity without authorization to speak on the matter.
“The only thing to be done about that is to prepare for people – the public has to know how many people die in nursing homes on a given day. And just because something is linked in time, doesn’t mean it’s the cause,” the official continued. “We’ve been saying it, and we’ve been telling other people to say it.”
Schaffner, who currently serves on the ACIP, said that his conversations with top CDC officials reflect a growing sense of nervousness over nursing homes being among the first in line.
“It’s actually been a bit of an alarm bell for everybody at the CDC,” Schaffner said. “The potential for misinterpreting medical events that occur in nursing homes is at the top of everybody’s consciousness.”
In order for a medicinal product, like a vaccine or a therapy, to receive an emergency use authorization from the FDA, the agency must determine whether the benefits of administering the product outweigh the risks. There is widespread agreement that the risks posed by COVID-19 to nursing home residents and the elderly are exceptionally high, and leadership at the CDC, FDA and the National Institutes of Health have all endorsed the ACIP guidelines.
The FDA has yet to finalize its label for recommended use of the vaccine, or its accompanying clinical guidance documents, and will only do so at the point at which it authorizes its emergency use, which could be soon.
The revelation in Britain this week that Pfizer’s vaccine could prompt severe allergic reactions provided new information about the vaccine to government regulators that was not produced in the clinical trials.
It was just one example of a potential, unanticipated bump in the road that might await Operation Warp Speed, the federal program organizing COVID-19 vaccine development and distribution, as it prepares to begin distributing vaccine doses across the United States.
At a critical advisory committee meeting on Thursday, where independent experts voted in favor of granting emergency use to Pfizer’s vaccine, FDA officials said the agency would investigate every adverse reaction that occurs in vaccine recipients.
A Pfizer representative told the hearing that immunocompromised individuals were excluded from the trial because it has “yet to be determined if different dosage is required” for them.
“We should be very closely monitoring where things can go wrong,” said Prashant Yadav, a supply chain expert at the Center for Global Development and former supply chain strategy leader at the Bill & Melinda Gates Foundation.
“In particular, for elderly in nursing homes, we do need to pay special attention to adverse events following immunization in our reporting system – and make it not just something that is laissez-faire, where we have a system and people report, but very actively go and monitor,” Yadav said.
An Operation Warp Speed official told McClatchy that the government had prepared a robust interagency system that will track all adverse events on a daily basis. “There will be incredibly active pharmacovigilance,” the official said, referring to the process of monitoring the safety of drugs that have reached the public.
Pfizer allowed individuals with several conditions to be a part of their advanced, Phase III clinical trial, including those with diabetes, Hepatitis B and C, stable HIV and stable chronic disease.
But several other categories that are likely to be represented among the first vaccine recipients were not included, including immunocompromised individuals and pregnant women among frontline workers.
The lack of this data leaves open the possibility of unanticipated complications, even if scientists and regulators have no specific reason to believe the vaccine will pose additional risk to the groups that were not included in the clinical trials.
“With some of these individuals, you have a compromised system to begin with, so the vaccine may not work as well or there may be severe side effects,” said Dr. Julie Swann, head of the Department of Industrial and Systems Engineering at North Carolina State University and an adviser to the CDC during its response to the H1N1 pandemic in 2009.
“Vaccine hesitancy and people not taking them is a worry,” Swann said. “I think that we’re going to see different aspects contributing to this.”
Independent experts and officials alike are cautiously optimistic that Operation Warp Speed – which has been training for months to distribute vaccines once they are authorized for use – is prepared for the complex task at hand.
Ensuring that the right vaccine deliveries get to the right locations on time will be critical to building public trust in the government program, experts said.
“I’m sure there will be glitches and hiccups – this is an extraordinarily complicated logistical operation, and we’ve never tried to do anything like this before,” said Dr. Eric Toner, senior scholar at the Johns Hopkins Center for Health Security, whose framework for distributing COVID-19 vaccines was cited as a resource by the National Academy of Medicine.
“There may be deliveries that are wrong, that go to the wrong place. We’re already seeing that states are surprised by how many doses they’re getting in the first batch, which is less than they had understood,” said Toner. “From the public’s perception, it may appear like delays or things going wrong, but this is part and parcel of trying to do something so complex for the first time.”
One White House official noted that governors were given the opportunity to essentially point to any location in their states and request the delivery of vaccine doses there – a “hand-to-mouth” service that places the onus on state and local officials to choose the most appropriate locations.
Supply chain experts are more concerned that, once the initial deliveries arrive at their intended destinations, state and local authorities handle the doses properly.
“My top concerns in the first phase are states which are receiving vaccines at predetermined hospitals and sites, and then sending them onward to lower-level health clinics or smaller facilities,” said Yadav. “That handling procedure is something that has not been tried and tested as some of the federal level planning has been, and it does carry the risk that product integrity could be compromised.”
Even if every vaccine shipment arrives at the right location, states risk wasting a large percentage of their doses if they are not administered before they expire – a problem in some rural areas, which have lower demand and less capacity to maintain the ultra cold temperatures required for storage.
The minimum order for a Pfizer vaccine shipment is 975 doses per box.
Swann said she has confidence in the delivery system that has been set up by Operation Warp Speed in partnership with industry experts such as UPS.
But some of the logistical issues may raise confusion and concern, she said.
“I think it’s going to be hard for people to know where the vaccine is and when they can get it,” Swann said. “I think it’s going to be hard for states to know where the vaccine has been used up and where there is leftover vaccine.
“There will be challenges to providers keeping up with inventory and reminders,” she continued. “And what I think it’s going to lead to is greater uncertainty, and some level of confusion, on what is happening when.”
