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Correcting this week’s misinformation: week of June 22, 2023

Were pharmaceutical claims about COVID vaccines false?

The Claim:

An interview of RFK Jr. on a podcast claimed that the COVID vaccine was approved under false pretenses or claims that it was 100% effective. The explanation about how this claim was made has to do with the number of COVID deaths during a placebo-controlled trial; twice as many people died from COVID who were given the placebo than were given the vaccine, thus allegedly leading pharmaceutical companies to claim the vaccine was 100% effective.

The Facts:

There are several problems with this statement from RFK Jr. First, his math is off, given that 2 is 200% –not 100%– of 1.

More importantly, the FDA approval of the Pfizer vaccine under an Emergency Use Authorization (EUA) in Dec 2020 was clear about the available effectiveness data, where it was specified that the vaccine was 95% effective in preventing COVID-19 disease. Neither in the EUA authorization nor the final authorization has it ever been claimed that the vaccine was 100% effective. A 100% effective vaccine would entirely eliminate the possibility of contracting a disease–something no vaccine claims to do.

Another issue with the claim is that the NTV (the number needed to be vaccinated to save one life) should have been given. This claim is based on the assumption that the only COVID endpoint of note is death.

Not only can COVID itself be debilitating and therefore worthy of prevention on its own, but when the vaccines were first authorized under EUA, the hospital systems were overwhelmed with COVID cases, and excess deaths occurred even in non-COVID situations due to the healthcare crisis. Preventing severe illness that leads to hospitalization and death saves people and our healthcare systems.

Why do newborns get a Hep B vaccine?

The Claim:

An American cardiologist has taken to Twitter to claim that Hepatitis vaccines are not necessary or safe for newborns, pointing to a claim that Hep B vaccines have only 5 days of safety monitoring.

The Facts:

This claim relies on package insert data, as opposed to actual clinical trial information. Vaccine inserts are legal documents and not medical or research documents. Looking at the actual clinical trial information for the Hep B vaccine shows that the “five days” were specifically for injection site non-serious adverse events (NSAEs). Researchers watched for serious events for the length of the study (5 months for that particular study), 14 days for systemic NSAEs (i.e., fevers), and five only days for the injection site NSAEs.

Hep B infection can lead to chronic Hep B. Chronic Hep B can last a lifetime and lead to serious illnesses such as cirrhosis and liver cancer. The younger you are when you get hepatitis B, the more likely it will become chronic. There is no cure for hepatitis B, but vaccines can prevent it.

The widespread implementation of Hep B vaccination programs, including the birth dose, has led to significant reductions in Hep B worldwide. By immunizing newborns, the goal is to achieve a high vaccination coverage rate and create a population with decreased Hep B transmission, ultimately reducing the burden of related diseases.

Can boosters cause ME/CFS?

The Claim:

An actress is gaining attention for her decision to end her life. She asserts that a COVID booster caused her to develop myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and possibly respiratory amyotrophic lateral sclerosis (ALS).

The Facts:

ME/CFS is a complex and poorly understood condition characterized by persistent fatigue, post-exertional malaise, and a range of other symptoms. At this time, there is no evidence that COVID vaccines used in the U.S. can cause ME/CFS or ALS. We did find one case report of ME/CFS symptoms after the Russian Sputnik V vaccine.

We do know that researchers have noted a correlation between COVID infection, Long-COVID, and ME/CFS, even after mild and asymptomatic cases. In fact, half of Long-COVID patients have chronic fatigue symptoms.

ME/CFS is tragic, but the best way to avoid ME/CFS is through vaccination.

ALS, also known as Lou Gehrig’s disease, is a neurodegenerative disorder that primarily affects the nerve cells responsible for controlling voluntary muscles.  We also found a case report of a viral vector COVID vaccine being temporally associated with ALS symptom onset. Interestingly, the patient in the case report had a family history of ALS. Research has pointed to a strong genetic link to ALS.

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