Pfizer Pushes Ahead for Its Third Booster Vaccine Despite Conflicting CDC and FDA Statements

·6 min read
Pfizer Pushes Ahead for Its Third Booster Vaccine Despite Conflicting CDC and FDA Statements
  • Pfizer officials have shared emerging data that suggests that its vaccine is less effective against preventing mild symptoms from contagious COVID-19 variants over time, with increasing ineffectiveness at the 6-month mark.

  • While company officials are now asking for emergency approval for a third booster dose to prolong immunity, officials at federal health agencies say a third shot is unnecessary at this time.

  • "Americans who have been fully vaccinated do not need a booster shot at this time," says CDC and FDA officials in a new joint statement.

  • Pfizer has publicly shared it's hoping to receive approval for its third booster shot in August.

If you've been vaccinated against COVID-19, there's a good chance you received a shot developed by teams at Pfizer or Moderna — a two-series mRNA vaccine that required you to sit for another "booster" dose within a few weeks of your first shot. While health experts were unsure if Americans would need additional shots to keep safe during the pandemic, new evidence amid a surge in COVID-19 cases related to what the World Health Organization calls the "Delta" variant suggests that you may need an additional shot sooner than you'd have guessed.

Company officials at Pfizer are touting new data that suggests that infection risk after six months is greater when it comes to the highly infectious Delta variant; figures published by the Wall Street Journal suggests that Pfizer's vaccine protected upwards of 65% of vaccinated individuals in an Israeli data subset collected in June and early July. This percentage is down a bit from earlier data points, which put total protection closer to 95%, according to Israel's Health Ministry.

Pfizer officials have reportedly asked officials at the Food and Drug Administration for an emergency green light for a third booster dose earlier this week, CNBC reports. Interestingly enough, health officials at the FDA as well as the Centers for Disease Control and Prevention have released a statement to the public before even receiving a formal request for another Pfizer vaccine dose.

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"Americans who have been fully vaccinated do not need a booster shot at this time," the joint release reads. "People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta… People who are not vaccinated remain at risk."

The joint statement also adds that an overwhelming majority of new COVID-19 cases and deaths are being attributed to those who have not sought out a vaccine.

This is in line with what Dr. Anthony Fauci, a longtime COVID-19 federal advisor as the director of the National Institute of Allergy and Infectious Disease, has been sharing with the public recently. "Right now, given the data and the information we have, we do not need to give people a third shot," Dr. Fauci told CNN this weekend. "That doesn't mean we stop there, however… there are studies being done now, ongoing as we speak, about looking at the feasibility about if and when we should be boosting people."

Do I need a third Pfizer shot yet?

Representatives from Pfizer and BioNTech (its development partner) have released statements and data suggesting that vaccinated individuals' immunity against COVID-19 may begin to weaken after 6 months, especially against new variants of the disease. But officials at the FDA and CDC maintain that more evidence is needed before any agency recommends a third dose for more than 79 million Americans who received a Pfizer vaccine this year.

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Health officials maintain that it is not clear if a booster shot will be needed to continue to provide full protection against mild COVID-19 symptoms. But the rise of disease strains like the highly contagious Delta variant — which has become the most virulent and dominant COVID-19 strain in America after first being recorded in late March, per Yale Medicine — points to signs that all manufacturers may have to create booster doses of their vaccines to ensure immunity through the winter season.

"While protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected," Pfizer officials have shared in a follow-up release. "Based on the totality of the data they have to date, Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months following the second dose to maintain [the] highest levels of protection."

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Currently, officials at the FDA will have to grant Pfizer what's known as "Emergency Use Authorization" before it can begin releasing another dose to the American public. When it's time to receive another dose of the Pfizer vaccine, it's likely that your initial provider — whether it be a clinic, pharmacy or your primary care provider — could be responsible for administering another shot.

When will Pfizer have booster doses available?

As Pfizer officials are planning to present data, findings and other materials to public health officials this week, you may be wondering if a third booster dose is imminent. Dr. Fauci explained that approval may not come as fast for pharmaceutical companies as it did last winter.

"There's a lot of work going on to examine this in real-time to see if we might need a boost. But right now, given the data that the CDC and the FDA has, they don't feel that we need to tell people right now you need to be boosted," he told CNN.

Officials at Pfizer have reportedly signaled that it's undergoing the process to get its booster vaccine approved currently, as CNN reports, and that it's angling to receive approval in August. It will soon publish additional data and findings on its vaccine's effectiveness over time as researchers continue to determine if Americans truly need additional shots this year.

Does that mean you'll be able to sign up for another Pfizer shot in August? Not necessarily. Even if officials at the FDA grant an emergency authorization early in the month, health experts have previously told Good Housekeeping that distribution for additional doses may be based on priority for risk groups. Meaning, those who are above a certain age or dealing with pre-existing conditions that mark them at high risk for severe COVID-19 illnesses may potentially be first in line for these booster shots.

It's too soon to know when and if Pfizer's latest rollout will occur this way, but definitely something to keep in mind as you plan things like late summer travel, back to school and holiday celebrations in the fall and winter.

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