On Monday, Pfizer Inc. (PFE, Financial) and BioNTech SE (BNTX, Financial) announced a trial of their Covid-19 vaccine has shown a “favorable safety profile” and a “robust” immune response in children ages 5 to 11. The announcement gave a small boost to Pfizer shares, but came hot on the heels of the Food and Drug Administration’s unanimous decision to not recommend widespread booster shots as of Sept. 17.
The trial group included 2,268 participants 5 to 11 years of age that were given a two-dose regimen of 10 micrograms according to the company’s press release. This dosage is a third of what is used for patients aged 12 and over. Overall, the Covid-19 vaccine was “well tolerated” throughout the test group and that any side effects seen by trial participants were comparable to those that were seen in participants aged 16 to 25.
“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose,” BioNTech CEO and co-founder Dr. Ugur Sahin said.
The trial also includes children 6 months to 2 years old and a third test group of children 2 years to 5 years old from the U.S., Finland, Poland and Spain across 90 clinical trial sites. The younger age groups are using a trial dosage of three micrograms, approximately a tenth of that used in adults. The results from these other trial groups are expected to come as soon as the fourth quarter of this year.
The results from the Pfizer-BionTech trial are planned to be submitted to the FDA, European Medicines Agency and other regulatory agencies as soon as possible. The companies also plan to submit the data for Emergency Use Authorization in the U.S. as they continue to accumulate the data needed for full FDA approval.
“Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Pfizer Chairman and CEO Albert Bourla said.
On Sept. 20, Pfizer (PFE, Financial) stock was up around 1% on the news before sinking to $44.03 per share with a market cap of $246.89 billion by midday. According to the GF Value Line, the stock is trading at a modestly undervalued rating.
Top guru shareholders in Pfizer include the Vanguard Health Care Fund (Trades, Portfolio), Pioneer Investments, Diamond Hill Capital (Trades, Portfolio), the T Rowe Price Equity Income Fund (Trades, Portfolio) and Richard Pzena (Trades, Portfolio).
Currently, Pfizer is the only company with a Covid-19 vaccine approved for children, and the FDA recommended boosters for those that are at high risk of infection. Should it gain FDA approval for children under 12, the company could be set to tackle the recent influx of pediatric cases as students run back to school. Comparatively, the company’s major competitors for vaccines, Moderna Inc. (MRNA, Financial) and Johnson & Johnson (JNJ, Financial), have only been authorized for adult usage.
The coming weeks are expected to see an expansion of booster recommendations according to Dr. Francis Collins, the director of the National Institutes of Health. Should Moderna and Johson & Johnson be included in these recommendations, they could see an uptick in demand across the country.
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