Safe Vaccines Can’t Be Rushed

By SAM URETSKY

According to US law, drugs must be shown to be safe and effective – but there are major caveats to that. First of all, “safe” essentially means safer than the disease or condition that they’re meant to treat. Also, it takes a long time to demonstrate safety – in some cases decades. One classic case was diethylstilbestrol (DES).

Diethylstilbestrol (DES) was an estrogen that was first manufactured in a laboratory in 1938, so it is called a “synthetic estrogen.” During 1938-1971, US physicians prescribed DES to pregnant women to prevent miscarriages and avoid other pregnancy problems. As a result, an estimated 5-10 million pregnant women and the children born of these pregnancies were exposed to DES. In 1971 a study identified DES as a cause of clear cell adenocarcinoma (CCA), a rare vaginal cancer in girls and young women who had been exposed to DES before birth. As early as 1953, there was evidence that DES was ineffective in preventing threatened abortion, but it took another 18 years to show that it was also unsafe.

In contrast to the usual prescription drugs, vaccines, in spite of the fears inspired by the anti-vaxxers, have an impressive record of safety. According to a Gallup poll in August, 35% of Americans would not get free, FDA-approved COVID-19 vaccine if one were ready. Pew Research in September had a different report: “About half of US adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today; nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May, a 21 percentage point drop.”

While vaccines may not be as effective as we could wish, their overall safety record is excellent. The Centers for Disease Control and Prevention (CDC) has a section on vaccine safety, discussing the conditions that have been blamed on vaccinations. In most cases these are post hoc ergo propter hoc arguments, which is the Latin for “After this, therefore because of this.” A typical example would be saying “every time I go to a Yankees game they win,” and taking credit for the team’s victory. In fact, most of the so-called cause and effect relationships are independent of each other. There have been serious medical tragedies that might be linked to vaccinations, but they have been fewer, and smaller than those associated with routine drugs, and in most cases could not be confirmed as due to the vaccine.

The worst of the vaccine tragedies was the so-called Cutter Incident. In 1955, some batches of polio vaccine, manufactured by Cutter Laboratories, contained live virus. Over 250 cases of polio and five deaths were attributed to the faulty vaccine. But, while vaccines are generally safe, they are often of limited effectiveness, particularly in view of the rapid rate of viral mutations. According to the CDC, the 2020 flu vaccine has been 50% effective against influenza B/Victoria viruses and 37% effective against influenza A(H1N1)pdm09. Also, in dealing with epidemics and pandemics, the overall effectiveness depends on both the efficacy of the vaccine, and the percentage of the population that gets the injection.

A report in the American Journal of Preventive Medicine, “Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Intervention,” attempted to estimate the efficacy and distribution of a vaccine to act alone either to prevent or reverse an epidemic. The authors estimate that to prevent an epidemic (reduce the peak by more than 99%), the vaccine efficacy has to be at least 60% when vaccination coverage is 100% That is, if everybody receives the vaccine, a 60% effective vaccine will prevent an epidemic. If only 75% of the population receives the vaccine, it would have to be 70% effective, and when the vaccine is only given to 60% of the population effectiveness would have to be 80%.

The World Health Organization (WHO) has set a target of 70% efficacy with consistent results in the elderly, but a minimal standard of 50%. Meanwhile, a team from the Howard Hughes Medical Institute has cataloged how nearly 4,000 different mutations alter SARS-CoV-2’s ability to bind to human cells.

We’ve spoken of a vaccine as if it would be a panacea. It won’t be. Just getting the vaccine to an adequate percentage of the high risk populations will be daunting – but given the safety record of modern vaccines, there is no reason to refuse a vaccine for fear of adverse reactions. The WHO goal is complete absence of serious adverse effects, but the minimum standard is “favorable benefit/risk profile in the context of observed vaccine efficacy; with no severe adverse events related to vaccination.” A WHO approved vaccine will meet the standard – safe and effective.

Sam Uretsky is a writer and pharmacist living in Louisville, Ky. Email sdu01@outlook.com.

From The Progressive Populist, November 1, 2020

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