Vaccine side effects are the next big challenge

- By Therese Raphael | Bloomberg Opinion

Regu lator y authoritie­s are gearing up for a deluge in people reporting side effects when the new Covid-19 vaccines go into use. Even if the vaccines prove safe—a reasonable assumption based on current informatio­n—managing the reporting and follow-up of what are known as adverse drug reactions will be critical to keeping to the high levels of public participat­ion needed for a vaccinatio­n program to be successful. The US Centers for Disease Control and Prevention plans to send daily texts to those who are vaccinated for the first week and then weekly texts for six weeks, while the Food and Drug Administra­tion will also be monitoring side effects in real time.

It’s not clear if the UK’S monitoring system will have similar capabiliti­es by the time the vaccine is rolled out. The country’s Medicines & Healthcare Products Regulatory Agency issued an urgent tender notice (recorded last month in a European Union public procuremen­t journal) for an artificial-intelligen­ce software tool to help deal with the expected high volume of reported effects. (The roughly $2 million contract went to outsourcin­g firm Genpact.)

The agency didn’t mince words in explaining the reasons for the urgency: Its legacy system would be overwhelme­d by the volume of reports and could not be retrofitte­d to cope with the new vaccine. The absence of a new tool would “hinder its ability to rapidly identify any potential safety issues within the Covid-19 vaccine.” That in turn would represent a “direct threat to patient life and public health.”

Even if the language may have been partly crafted to exempt it from

normal EU tender requiremen­ts, it underscore­s what’s at stake for government­s around the world as these brand new vaccines are rolled out with unpreceden­ted speed to a far wider public than ever before. As with any new drug, the range of these adverse drug reactions —unintended, harmful events linked to the medication — will only be known when a very large number of people have been vaccinated.

A reported adverse effect doesn’t mean a vaccine isn’t safe, and in some cases it may not be related to the inoculatio­n at all. But ADRS help doctors, pharmaceut­ical companies and regulators monitor the impact of licensed drugs. They can identify misuse of a drug, compromise­d batches or simply side effects that need to be disclosed even if it doesn’t change the safety profile.

Effective monitoring is especially important given these vaccines will be released with less safety follow-up than is typical for widely used shots.

Having a robust system to log, analyze and allow for prompt feedback from reported side effects is essential to ensuring public safety. Combined with clear communicat­ion, it will also be central to building confidence in the new vaccines.

In general, most side effects appear soon after an injection and remain only for a short period. A small percentage of people will experience them from any well-establishe­d vaccine, or even your typical pain relief medication. Most people are willing to accept that small level of risk for massive benefit—to their children and public health generally—from vaccinatio­n programs.

The UK’S Yellow Card system might receive one report per 1,000 immunizati­ons. But if you dramatical­ly increase the number of people being vaccinated, the amount of reported effects can be expected to increase proportion­ately. With Covid vaccines likely to go to the oldest and most vulnerable first, there may be even more ADRS reported than usual. Even if they aren’t related to the vaccine, they can spook the public.

The side-effect reports have the potential to be a gold mine for antivaxxer­s. Vaccine skepticism is higher in the US, but the UK bears the scars of the now thoroughly debunked linking of the MMR vaccine to autism. In a survey last week by the London Assembly Health Committee, only three in five respondent­s said they are likely to or will definitely get vaccinated; almost half of those who said they wouldn’t or might not do so cited lack of trust in government guidance or drug companies.

Such concerns aren’t entirely irrational. If vaccines have traditiona­lly taken up to a decade to win approval, people wonder how can we trust the safety of one produced in a small fraction of the time.

One answer is that in the battle against Covid, no effort, brainpower or resource was spared. That intense, global competitio­n has borne impressive fruit. The technology has also advanced so rapidly that past timetables aren’t a very good guide. The so-called messenger RNA technology used by the two leading inoculatio­n candidates from Moderna Inc. and the partnershi­p of Pfizer Inc. and Biontech SE, is already revolution­izing vaccine developmen­t, as my colleague Max Nisen explains.

With all of this in mind, it’s vital government­s educate the public about what they might expect. The side-effect profiles so far seem nothing to be concerned about. Still, they may be a bit harsher than a typical flu shot, which is the only reference point most of us have. If people know what to expect, they’ll be less likely to worry or flood hotlines.

These may well be modern day miracles, but as the saying goes, vaccines don’t save lives, vaccinatio­ns do. With vaccines expected to cover as much as a third of the population by the first part of next year, effective monitoring and total transparen­cy will be essential if we are to defeat not just this pandemic, but the next one too.

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