Covid-19: Doctors in Norway told to assess severely frail patients for vaccination

Dear Editor

On December 1, 2020 I received an email from the distinguished author of an American textbook of pediatric infectious diseases. He was severely critical of my November 13, 2020 rapid response (https://www.bmj.com/content/371/bmj.m4374/rr-4), particularly my calculation that 256 individuals would have to receive Pfizer’s vaccine to prevent a single Covid-19 illness. In the language of the clinical epidemiologist, 256 is the Number Needed To Vaccinate (NNTV). It is the vaccine equivalent of the Number Needed To Treat (NNTT), which is used to measure the real-world benefit of drugs and procedures for individuals. (Sackett et al, Clinical Epidemiology, 1991) Application of the concept to vaccines is controversial. Most public health authorities emphasize the population benefit of vaccines and herd immunity over individual benefit, and it is no surprise that manufacturers support this emphasis because it fosters greater vaccine uptake. Others believe that NNTV is a useful measure of the impact and cost-effectiveness of immunization programs. (Hashim et al, Vaccine 2015;33:753)

Fresh questions about safety and effectiveness have been aroused by a report of 33 deaths in elderly Norwegians shortly after their first dose of Pfizer’s Covid-19 vaccine. (Torjesen, BMJ 2021;372:n167, Jan 19) Our knowledge is limited, but NNTV is a straightforward way to quantitate individual benefit. The latest published information indicates that the absolute risk reduction (ARR) by the vaccine for any Covid-19 illness is 0.0046 for individuals 65 and older. (Calculated from Table 3 in Polack et al, NEJM 2020;383:2603, Dec 31) The NNTV is 1/0.0046=217. This means that 216 old people will derive no benefit but will be subject to adverse effects….There are at least two qualifications for this calculation: first, the NNTV for severe illnesses and deaths is likely to be much higher; second, NNTV is likely to change with time as the calculated ARR and vaccine effectiveness change with time.

I hope the foregoing will not be misquoted or used on social media (which I rigidly avoid) in a misleading way. Meanwhile, we still have a lot to learn about Covid-19 vaccines, something we should know from our experience with influenza vaccines (https://www.bmj.com/content/371/bmj.m4037/rr-3).

ALLAN S. CUNNINGHAM 28 January 2021

Dear Editor,

Reports from Norway do carry a distinct message. Though the elderly (particularly with comorbid conditions) have borne the brunt in the reported Covid mortality, it may be erroneous to club the 'elderly' togeter into a homogeneous entity.

In fact, the concepts of 'prefrailty', 'Frailty Syndrome' tend to be under recognised or hardly taken into account in clinical contexts. Any minor clinical condition or external administration can tip the scales against the frail with a highly compromised 'internal milieu'. The vaccine programme and schedules are operational on a global scale, and let vaccine administration, without adequate prior clinical assessment in the elderly, not turn into a repetitive adversity.

Dr Murar E Yeolekar, Mumbai.

Dear Editor

The deaths of frail elderly after vaccination , and subsequent guidance to Norwegian doctors to perform an assessment instead of issuing universal guidance on vaccinations for their patients, has reanimated an old medical concept: fitness for vaccination.

Vaccination used to be an individual decision, made jointly by patient and doctor, that the benefits of a vaccine for that patient exceeded the expected harms. Patients paid small sums to be vaccinated.

Payment systems changed, and the government or insurance companies took over paying for vaccinations. Then the Affordable Care Act in the US waived all copayments, allowing pharmacies and grocery stores to advertise "free" vaccinations while you shop. Pediatricians were given bonuses if they reached assigned target levels of "fully vaccinated" children, which could amount to tens of thousands of dollars.

Vaccine mandates were brought in, and became tighter over the ensuing years. Children who are not fully vaccinated cannot attend school in certain states, regardless of their religious or philosophical orientation.

To make the mandates work, the concept of "fitness for vaccination" was undermined, then deeply buried. All vaccines became "safe and effective."

It is a tragedy that deaths and anaphylac events have occurred following Covid vaccinations. But maybe some good will come of it, by focusing awareness on the fact that vaccines are drugs, whose use is never absolutely risk free. Let us hope that the idea of establishing fitness for vaccination has been permanently disinterred.