COVID-19 hospitalizations and deaths are rising in the United States as the highly infectious Delta variant of the SARS‐CoV‑2 virus has become the dominant strain in the country. These serious cases are almost entirely limited to people who are not vaccinated against the virus; for the vaccinated, infection rates are much lower and nearly all infections are no more troublesome than a cold or — at worst – a bout of the flu, and often go unnoticed altogether.
COVID-19 caused at least 11 percent of all U.S. deaths in 2020, making it the third leading cause of death, behind only heart disease and cancer. So far in 2021, COVID has killed more than 200,000 more Americans, meaning it will be a top killer this year too. Yet, about a third of American adults haven’t gotten vaccinated against the virus. This is beyond baffling; if there were a highly effective, very‐low‐risk, zero‐out‐of‐pocket‐cost medication against becoming seriously ill or dying of cancer (and that also lessens your family’s risk of getting cancer), you’d take it, right?
For many of the unvaccinated, refusal to get inoculated is linked to political, religious, and racial identity. Some also say they don’t want the shot because it is “experimental,” a justification that has been defended by politicians and TV talking heads. A recent survey of unvaccinated Americans found that 30 percent said they would be more willing to get immunized if the vaccines were fully approved by the U.S. Food and Drug Administration. Many anti‐vaxxers argue that government efforts to get people to take an experimental medication are big government run amuck.
Thing is, in saying the vaccines are “experimental,” these people are relying on big government to justify their going unvaccinated.
To date, nearly 350 million doses of the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines have been administered in the United States, and hundreds of millions more have been given worldwide, in a drive that has been ongoing for more than half a year. For all intents and purposes, these medications stopped being experimental a long time ago.
All intents and purposes save one, that is. The vaccines, like all medicines introduced in the United States since early in the 20th century, are available only by permission of the U.S. government. Ordinarily, the FDA only approves a medication after extensive testing to show its safety and effectiveness. The agency has long been criticized for requiring far more testing than is reasonable, thereby delaying the introduction of beneficial drugs to the U.S. market. Currently, the FDA is allowing the SARS‐CoV‑2 vaccines only under Emergency Use Authorization (EUA), meaning they haven’t received the agency’s full blessing. Given the national COVID emergency and early data indicating the medicines’ high degree of safety and effectiveness, the FDA decided to allow their administration. (Worth noting: the FDA is keeping other SARS‐CoV‑2 vaccines off the U.S. market despite evidence of their safety and efficacy.)
Put simply, the vaccines are not experimental; they just don’t have the government’s full approval. And the FDA is notorious for its risk‐aversion in granting approvals. To receive the agency’s blessing, a medication must undergo three phases of agency‐reviewed testing. Roughly speaking, Phase I focuses on the product’s safety, Phase II examines its effectiveness in treating its targeted medical condition, and Phase III studies its effects in the presence of complicating factors. The three available vaccines had each completed Phases I and II and were well into Phase III with great results when they were granted EUA. Since then, plenty more data have been collected showing the medicines’ safety and effectiveness. Pfizer/BioNTech began the application process for full approval back on May 7 and completed it in June; Moderna started the process on June 1 and should complete it soon. J&J is expected to begin the process in the coming weeks. Yet the FDA probably won’t grant approval to Pfizer/BioNTech until September at the earliest and could drag it out to early next year. Meanwhile, COVID goes merrily on.
So, yes, the anti‐vaxxers are right that the SARS‐CoV‑2 vaccines do not have full FDA approval. But when they use that justification, they’re just relying on the foot‐dragging and risk‐aversion of a federal agency and ignoring the ample evidence of COVID-19’s danger and the safety and efficacy of the vaccines.
Meanwhile, the government has doled out all sorts of benefits because of the COVID emergency, from helicopter money, to enhanced unemployment benefits, to blocking housing foreclosures and evictions. Yet there are plenty of open jobs around the country. Perhaps these assistance efforts were needed in the first year of the emergency, but it’s difficult to justify continuing them when safe and effective vaccines against the virus are readily available. With rare exceptions for people with medical conditions that prevent them from being inoculated, those who are avoiding immunization should not receive government COVID benefits. And they shouldn’t justify themselves by using the government to claim the vaccines are experimental. Their doing so is as big‐government as it gets.
