Editor's Note: Kent Sepkowitz is a CNN medical analyst and physician and infection control expert at Memorial Sloan Kettering Cancer Center in New York. The opinions expressed in this comment are yours. See more opinion at cnne.com/opinion
(CNN) - On Monday, the Financial Times reported that the White House may circumvent standard Food and Drug Administration (FDA) regulations to speed up the use of the so-called Oxford coronavirus vaccine.
The possible shortcut appears similar to the administration's decision on Sunday to bypass the same regulatory body to, as the president put it, break "last week's traffic jam" by granting emergency use authorization for convalescent plasma treatment. This was despite previous skepticism from some senior government health officials that enough data existed to justify such action, according to a CNN source.
As with the convalescent plasma decision, this firm approach of setting aside regulations to introduce a vaccine without a full study studied is a big 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, of whom only half (543 people) received the Oxford product. (The other half received a different vaccine already approved for one type of meningitis.)
The side effect profile of the Oxford vaccine is concerning, although not surprising. Among the participants, who were healthy, 91% white, and 35 years old on average, more than half reported headaches, fatigue, chills and a feeling of fever.
18% developed objective fever. These symptoms were substantially more frequent than in the control group that received the meningitis vaccine. While these are relatively common side effects that generally pose no threat, it is important to fully understand all the risks associated with the vaccine and how they may affect the various demographics that might be vaccinated.
Without this knowledge, it is difficult to be completely convinced of the safety of the vaccine, especially if it is administered widely. There is a predictable problem for any vaccine as it moves from a carefully selected clinical trial to real-world use: people who need the product most are almost always excluded from early studies because they do not meet the 'eligibility criteria' , the study rules that almost never allow the participation of people with comorbid conditions.
This means that we do not have information on how safe the vaccine is in the elderly, people with severe heart problems, cancer, diabetes or other weaknesses - the exact population that needs the vaccine most. And relevant to COVID-19 and the Oxford data so far: Few participants have been Black or Hispanic, groups with higher rates of severe COVID-19 illness.
In other words, we don't know how the average older American with a pre-existing condition or two will respond to the vaccine, both from a protection and side-effect perspective, if President Trump rushes in and makes it available for use.
On a practical level, this will add substantial confusion to patients and physicians around the world. For example, if someone develops a headache and fever one day after the vaccine, it is easy to ignore the symptoms as vaccine-related in a healthy 35-year-old volunteer.
But what about a newly vaccinated 80-year-old grandmother with heart problems? What if the fever speeds up your pulse and causes chest pain? Should I go to an emergency room?
The problem is more than one or ten or 1,000 patients. Given the already vaccinated nature of some in the U.S. (including Trump himself not long ago), some stories of possible toxicity could sink the entire program, leaving us both unvaccinated and more vaccine-averse for the next. promising product to be presented.
This transition from a promising program to a functional program has been a problem throughout Trump's efforts to combat COVID-19. As with diagnostic tests, it is one thing to have equipment or supplies, but it is another thing to implement a program.
You can't just declare, “We have a vaccine! Come get it! » and hope things work out.
The basics are simple: to develop a program, you need an implementation plan. So you need people to turn that plan into a manageable day-to-day schedule. And this must be national, not local.
So there are myriad issues that need to be resolved before any UK covid-19 vaccine arrives, including:
Management is likely asking these questions. We know that the White House is aware of the safety concerns, or at least it was a few weeks ago when the Russian Sputnik V vaccine became the world's first registered COVID-19 vaccine. Russia has not published complete data, not even many, on this vaccine.
Then White House Press Secretary Kayleigh McEnany stated that "our vaccines [in the US] go through a rigorous phase 3 clinical trial, in which we have 30,000 people we test to make sure that they are perfectly healthy to move on. 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 a generalized vaccination with a novelty or a series of novel agents. But even with a lot of planning, this is a very big task.
I participated in the smallpox vaccination program in 2002 as a member of the National Smallpox Vaccine Safety Team. Our role was to help ensure that the nationwide launch of the smallpox vaccine, planned for millions of people, including (mostly young and healthy) military and healthcare workers, was safe and that every possible serious side effect was screened for. carefully.
Before the first vaccine was administered, we spent months in conference calls thinking about how to get the job done efficiently, fairly, and decisively. And then once people were vaccinated, we spent more months reviewing clinical events.
Safe implementation of the COVID-19 vaccine is possible if a similar approach is followed. I am sure that US public health professionals are working on this task. But the group must have the time, data, and independence to work together in the public interest.
Most importantly, politicians should not ridicule them as weak and bureaucratic, troublemakers, contenders, timid and indecisive, perhaps even as those who are unwilling to push America forward, whether for political reasons or not. They are up to the task.
The stakes are high: Without time, data, and independence, the US Covid-19 vaccination program will become the latest in a catastrophic series of Covid-19 failures that have led to unnecessary illness and death.
covid-19