Rushing for a Covid-19 vaccine before getting full data would be a huge mistake (opinion)

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The possible shortcut appears similar to the administration’s decision on Sunday to bypass the same regulator to, as the President put it, break “last week’s deadlock” by granting permission to use it. emergency for convalescent plasma treatment. This despite previous skepticism by 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 rigorous approach of setting aside regulations to introduce an incompletely studied vaccine is a huge mistake. The Oxford vaccine, while showing promise, is still in the early stages of clinical development.

We have seen published information on 1,077 healthy volunteers, of which 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 cause for concern, but not a success. Of the healthy 91% white participants with an average age of 35, more than half reported headaches, fatigue, chills and a feeling of fever.

Eighteen percent developed an objective fever. These symptoms were significantly more frequent than in the control group that received the meningitis vaccine. While these are relatively common side effects that are usually not a threat, it is still important to understand all of the risks associated with the vaccine and how they might affect various demographics that may 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 with any vaccine as it moves from a carefully curated clinical trial to real-world use: The people who need the product most are almost always left out of early studies because they don’t respond to ” eligibility criteria ”- study rules that almost never allow people with comorbid conditions to participate.

This means that we have no information on the safety of the vaccine in the elderly, those with severe heart problems, cancer, diabetes, or other frailties – the exact population that needs the vaccine most. And relevant to Covid-19 and the data from Oxford so far, few participants were blacks or Hispanics, groups with higher rates of severe illness from Covid-19.

In other words, we don’t know how the average older American with a comorbidity or two will respond to the vaccine – both from a protection standpoint and side effects standpoint – if President Trump skips the gun and makes it available. for use.

On a practical level, this will add considerable confusion to patients and physicians around the world. For example, if someone develops a headache and fever a day after the vaccine, it is easy to ignore vaccine-related symptoms in a healthy 35-year-old volunteer.

But what about an 80-year-old grandmother who just got the vaccine and suffers from heart problems? What if the fever accelerates her pulse, causing chest pain? Should she go to the emergency room?

The problem is more than just one or ten or a thousand patients. Given the already nervous nature of some vaccines in the United States (including Trump himself not so long ago), a few stories of possible toxicity could sink the whole agenda, leaving us both unvaccinated and more averse to vaccines for the next promising product that arrives. .

The other way to fight back against Covid-19

This transition from a great promise to a functioning program has been a problem throughout Trump’s efforts to fight Covid-19. As with diagnostic testing, it’s one thing to have equipment or supplies, but it’s another to implement a program.

You can’t just say, “We have a vaccine! Come and get it! And I hope things are going well.

The basics are simple: to implement a program, you need an implementation plan. Then you need the people to turn that plan into a manageable daily program. And it must be national, not local.

Then there are countless issues that need to be addressed before any Covid-19 vaccine arrives from the UK, including:

  1. Who will get the vaccine first? Young people? Old? Critical workers? And who will decide?
  2. Where will the vaccinations be given? Clinics? Hospitals? Military sites?
  3. Who will administer the vaccines? Doctors? Pharmacists? Nurses? Will they be certified? Are they compensated if they cause injury?
  4. Who will clean the examination room after the vaccine is administered? Will he need a deep scrub at the Covid-19 level?
  5. How many vaccines will be given per day? How much per hour?
  6. AstraZeneca, which has partnered with Oxford to develop the vaccine, will it be protected from liability? Will medical insurers have to pay for illnesses related to an unapproved vaccine? Back in the days of the Ford-era swine flu vaccine rollout, these issues were particularly difficult.
  7. Who should the vaccinated 80-year-old grandmother call the next day when she has a headache and a fever? The local doctor’s office? A national 800 number?
  8. Who will collect safety information? The current federal vaccine adverse event reporting (VAERS) system is voluntary and there is no other national system. Who will review this information and determine if the fever and headache are indeed related to the vaccine or some other cause?
  9. Will the patient have to pay for the vaccine? Will there be a fee for using the facility and a fee for the person administering the vaccine? This was another topic of debate for President Ford.
  10. Given the accelerated timeline, will people be properly followed – as they would be in a Phase 3 clinical trial – so that we can see if, in fact, the vaccine actually works?

The administration is probably asking these questions. We know the White House is aware of the security 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 released full, or even extensive, data on this vaccine.

Then White House press secretary Kayleigh McEnany said, “Our vaccines [in the US] go through a rigorous phase three clinical trial, where we have 30,000 people we test to make sure it’s perfectly healthy to move forward. So that’s the kind of standard we have for American vaccines, and it’s important that we do it. ”

We have to be convinced that a lot of work has been done behind the scenes to prepare for a widespread vaccination with a novel or a series of new agents. But even with a lot of planning, this is a very important 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 deployment of the smallpox vaccine, planned for millions of people, including military and health workers (mostly young and healthy), was safe and that every side effect serious potential was carefully considered.

Before the first vaccine was given, we spent months on a conference call thinking about how to get the job done efficiently, fairly and decisively. And once people were vaccinated, we spent over months reviewing clinical events.

Safe deployment of a Covid-19 vaccination is possible if a similar approach is followed. I am convinced that American public health professionals are currently working on this task. But the group must have the time, the data and the independence to work together in the public interest.

Equally important, they shouldn’t be ridiculed by politicians as wimps and bureaucrats, blockmakers, stallers, nervous Nellies, maybe even Deep Staters card holders who don’t want to move America forward – either for for political reasons, or because they are not in good shape. for the task.

The stakes are extremely high: Without time, without data and without independence, America’s Covid-19 vaccination program will become the latest in a catastrophic string of Covid-19 failures that have resulted in unnecessary illness and death.

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