Editor’s Note: Kent Sepkowitz is a CNN medical analyst and a physician and infection control expert at Memorial Sloan Kettering Cancer Center in New York. The views expressed in this commentary are his own. View more opinion at CNN.
The possible shortcut seems similar to the administration’s decision on Sunday to circumvent the same regulatory body to, as the President said, break “the logjam over the last week” by granting emergency use authorization for convalescent plasma treatment. This was despite prior skepticism from some top government health officials that enough data existed to warrant such action, according to a CNN source.
As with the convalescent plasma decision, this tough-guy approach of pushing aside regulations to introduce an incompletely studied vaccine is an enormous mistake. The Oxford vaccine, while promising, is still in the early stages of clinical development.
We have seen published information on 1,077 healthy volunteers, only half (543 people) of whom received the Oxford product. (The other half received a different already approved vaccine for a type of meningitis).
The side effect profile of the Oxford vaccine is concerning, though not a showstopper. Among the participants, who were healthy, 91% white and 35 years old on average, more than half reported headache, fatigue, chills and feeling feverish.
Eighteen percent developed objective fever. These symptoms were substantially more frequent than in the control group who received meningitis vaccine. While these are relatively common side effects that usually do not pose a threat, it’s still important to fully understand all the risks associated with the vaccine and how they might affect various demographics who might be vaccinated.
Without this understanding, it is difficult to be fully confident about the safety of the vaccine – especially if it is given broadly. There is a predictable problem for any vaccine as it moves from a carefully curated clinical trial to use in the real world: people who need the product most are almost always excluded from the early studies because they don’t meet “eligibility criteria” – the rules of the study that almost never allow people with co-morbid conditions to participate.
This means that we have no information on how safe the vaccine is in older people, those with serious heart problems, cancer, diabetes, or other frailties – the exact population most in need of the vaccine. And relevant to Covid-19 and the Oxford data thus far, few participants have been Black or Hispanic, groups with higher rates of severe Covid-19 disease.
In other words, we don’t know how the average older American with a co-morbidity or two will respond to the vaccine – both from perspective of protection as well as side effects – if President Trump jumps the gun and makes it available for use.
At a practical level, this will add substantial confusion for patients and doctors everywhere. For example, if someone develops a headache and fever a day after the vaccine, it is easy to shrug off the symptoms as vaccine-related in a healthy 35-year-old volunteer.
But what about an 80-year old just-vaccinated grandmother with heart problems? And what if the fever speeds up her pulse, causing chest pain? Should she go to an emergency room?
The problem is more than just one or ten or a thousand patients. Given the already vaccine-skittish nature of some in the US (including Trump himself not so long ago) a few stories of possible toxicity could sink the entire program, leaving us both unvaccinated and more vaccine-averse for the next promising product that comes along.
This transition from big promise to functioning program has been an issue throughout the Trump efforts to fight Covid-19. As with diagnostic testing, it is one thing to have equipment or supplies but it is another thing altogether to implement a program.
You can’t just declare, “we have a vaccine! Come and get it!” and hope things work out.
The basics are simple: To implement a program, you need an implementation plan. Then you need people to turn that plan into a manageable the day-to-day program. And this must be national, not local.
Then, there are countless issues that must be resolved before any Covid-19 vaccine arrives from the UK, including:
- Who will receive the vaccine first? Young people? Old? Critical workers? And who will decide?
- Where will the vaccinations be given? Clinics? Hospitals? Military sites?
- Who will administer the vaccines? Doctors? Pharmacists? Nurses? Will they be certified? Are they indemnified if they cause injury?
- Who will clean the exam room after the vaccine is given? Will it need a Covid-19 level deep scrub?
- How many vaccines will be given a day? How many per hour?
- Will AstraZeneca, which partnered with Oxford to develop the vaccine, be protected from liability? Will medical insurers be asked to pay for medical illnesses related to an unapproved vaccine? In the Ford era rollout of the swine flu vaccine, these were particularly difficult issues.
- Who should the vaccinated 80-year old grandmother call the next day when she has a headache and fever? The local doctor’s office? A national 800 number?
- Who will gather information on safety? The current federal Vaccine Adverse Event Reporting System (VAERS) is voluntary and no other national system exists. Who will review this information and determine if fever and headache are indeed vaccine-related or from another cause?
- Will the patient be asked to pay for the vaccine? Will there be a fee to use the facility and a fee to the person giving the vaccine? This was another area of debate for President Ford.
- Given the expedited timeline, will people be properly tracked – as they would be in a phase 3 clinical trial – so we can see if, in fact, the vaccine actually works?
The administration is likely asking these questions. We know that the White House is aware of the safety concerns, or at least was a few weeks ago when the Russian Sputnik V vaccine became the first registered Covid-19 vaccine in the world. Russia has not released full, or even much, data on this vaccine.
Then, White House press secretary Kayleigh McEnany stated that “Our vaccines [in the US] go through rigorous phase three clinical trial, where we have 30,000 individuals that we test to make sure it’s perfectly healthy in moving forward. So that’s the kind of standard we have for American vaccines, and it’s important that we do that.”
We have to trust that a lot of work has been done behind the scenes to prepare for a widespread vaccination with a novel or series of novel agents. But even with lots of planning, this is a very large task.
I was involved in the smallpox vaccine program in 2002 as a member of the national Smallpox Vaccine Safety team. Our role was to help assure that the national roll-out of smallpox vaccine, planned for millions of people, including (mostly young and healthy) military and healthcare workers, was safe and that each potential serious side effect was carefully scrutinized.
Before the first vaccine was administered, we spent months on conference calls thinking about how to efficiently, fairly and decisively perform the task. And then once people were vaccinated, we spent more months reviewing clinical events.
A safe rollout of a Covid-19 vaccination is possible if a similar approach is followed. I am sure that US public health professionals are right now at work on this task. But the group must be given the time, data and independence to work together in the public interest.
As importantly, they must not be derided by politicians as wimps and bureaucrats, logjam-makers, stallers, nervous Nellies, maybe even card carrying Deep Staters who are unwilling to push America forward – either for political reasons or because they aren’t fit for the task.
The stakes are extremely high: without time, data and independence, the US Covid-19 vaccine program will become the latest in a string catastrophic string of Covid-19 failures that have led to unnecessary disease and death.