Pfizer recently released updated topline findings from an examination of 927 confirmed symptomatic COVID-19 cases seen in their pivotal Phase 3 investigation, observed through March 13, 2021, revealing that the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3 percent effective against COVID-19 from seven days to six months following the second dose. The vaccine was 100 percent effective against severe illness as defined by the CDC, and 95.3 percent effective against severe COVID-19 as defined by the US Food and Drug Administration (FDA). Safety data from the Phase 3 study was also collected from more than 12,000 vaccinated participants who have a follow-up time of at least six months after the second dose.
The headlines claiming the vaccine is “100% effective in teens” are highly misleading. To clarify, the vaccine is 100% effective against severe illness. This does not mean that the vaccine is 100% effective against the virus.
What is even more confusing about these claims is that despite claiming 100% efficacy according to the U.S. Centers for Disease Control and Prevention (CDC) guidelines, the CDC specifically stated this week, “While COVID-19 vaccines are working well, some people who are fully vaccinated against COVID-19 will still get sick, because no vaccines are 100% effective.”
It is important to understand that the research shows the vaccine is very safe and effective against the virus.
“These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”
“It is an important step to further confirm the strong efficacy and good safety data we have seen so far, especially in a longer-term follow-up,” said Ugur Sahin, CEO and Co-founder of BioNTech. “These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population.”
Despite the efficacy of the vaccine, it is also important to be correctly informed. The conflicting claims made by both the CDC and the companies producing the vaccine highlight the discrepancies in communication that have been observed since March 2020.
Moderna announced Tuesday morning that their vaccine is also 100% effective in adolescents, aged 12-17 years old. Despite the claims already being made, the results have not yet been peer reviewed or published.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents,” Moderna CEO Stephane Bancel said in a press release. “We remain committed to doing our part to help end the COVID-19 pandemic.”
The injection was shown to be 93 percent effective after one dose , according to the company. Because children are less prone to become critically sick, Moderna calculated Covid-19 using the criteria provided by the Centers for Disease Control and Prevention– only one symptom and a positive Covid test are required.
More than 3,700 teenagers participated in the phase 2/3 trial Moderna cited on Tuesday. According to the company, no cases of Covid were found in individuals who received two doses of the vaccine, whereas four cases were found in the placebo group.
The news release reported that Moderna’s vaccine was between 93% and 100% effective in protecting against symptomatic COVID in a trial of teens, depending on whether extremely mild cases were included in the tally.
Again, claiming the vaccine is ‘100% effective’ is highly misleading, as mild and asymptomatic Covid cases are not included in that measurement. According to new research reported by the CDC’s latest Morbidity and Mortality Weekly Report, “Two-thirds of nonhospitalized COVID-19 patients had at least one outpatient visit that resulted in a new diagnosis within six months of being diagnosed with the virus.” If one is following the CDC’s recommendations, mild cases of Covid should not be ignored.
The unnecessary claims of 100% efficacy, which contradict previous claims made by the CDC, are misleading and contribute to further distrust among health officials and the general public. Regardless, the Moderna and Pfizer vaccines have both shown to be safe and effective in adults and adolescents.
Moderna stated that the company continues to collect safety data, and an independent safety committee is monitoring the data. Study participants will be followed for 12 months post-second dose to determine long-term protection and safety.