On June 1, drug giants Pfizer, Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) completed their application to the U.S. Food and Drug Administration (FDA) for the emergency use authorization (EUA) of their COVID-19 vaccine for children six months to under five years of age. The FDA has acknowledged the application but has set a timeline of June for the final approval.
Last month, Pfizer announced that its vaccine showed 80.3% efficacy in children six months to under five years of age. This study was taken seven days after the third dose of the vaccine shot was administered. The study also stated that the vaccine “demonstrates strong immune response, high efficacy, and favorable safety in children six months to under five years of age following the third dose.”
Pfizer’s advisable three booster shot dosage for children in this age group is three micrograms each, which is one-tenth of the dose prescribed to adults.
The FDA’s response to Pfizer and BioNTech’s EUA application states, “We recognize parents are anxious to have their young children vaccinated against COVID-19 and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach.”
Meanwhile, Moderna (MRNA) is also awaiting approval of its two-dose Comirnaty shot for children under age six.
The FDA is set to have a meeting of its independent advisory panel, the Vaccines and Related Biological Products Advisory Committee, on June 15 to discuss the EUA requests for both Pfizer and Moderna’s shots for young children.
If the meeting goes well and the Centers for Disease Control and Prevention’s (CDC) independent advisers agree, then the COVID-19 vaccine shots for children in this population could be available by the end of June.
However, a poll from the Kaiser Family Foundation showed that only 18% of parents are ready to vaccinate their children as soon as the shot is available. However, 27% parents are completely against vaccinating young children, and 11% said they will vaccinate kids only if schools demand it. The other 38% are in the wait-and-watch segment.
Stock Prediction
Based on six Buys and nine Holds, analysts have a Moderate Buy rating on the stock. The average Pfizer price target of $59.15 implies 12.28% upside potential to current levels. Meanwhile, PFE stock has lost 5.5% year to date.
Stock Investors
TipRanks’ Stock Investors tool shows that investor sentiment is currently Very Negative on Pfizer, with 1.6% of portfolios tracked by TipRanks decreasing their exposure to PFE stock over the past 30 days.
Ending Note
Although Pfizer has remained one of the major beneficiaries from the COVID-19 outbreak, its slowdown is adding pressure to all pharmaceutical companies alike. The massive COVID-19 vaccine sales boosted the stock’s performance in the past and it’s now up to the company to bolster its sales from its other pipeline of drugs and vaccines, once the virus fades away.
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