COVID-19 Roundup: Latest on Pfizer Booster for Those 65-Plus & Those at High Risk; Data on Lower-Dose Vaccines for Kids, 5-11; and More

FDA Approves Pfizer-BioNTech Booster Shots for Those 65-plus, Certain Others at ‘High Risk’

The U.S. Food and Drug Administration (FDA) has amended the “emergency use authorization” for the Pfizer-BioNTech COVID-19 vaccine to allow for use of a “single booster dose” to be administered at least six months after being fully vaccinated with the initial 2-shot regimen.

But the Pfizer booster shot approval only applies to individuals 65 years of age and older; and the following:

• People 18 through 64 years of age at high risk of severe COVID-19 because of underlying health issues; and
• People 18 through 64 years of age whose frequent institutional or occupational exposure to COVID-19 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

Individuals at high risk to institutional or occupational exposure include “healthcare workers, teachers and day-care staff, grocery workers and those in homeless shelters or prisons, among others,” the FDA stated. Separately, scientific advisers to the U.S. Centers for Disease Control and Prevention (CDC) signed off on most of the FDA’s guidelines.

The CDC advisers Thursday endorsed the FDA’s approval of the Pfizer third doses for those 65 and older, and also recommended that people aged 18- to 64-years-old with underlying medical conditions get the third shot. The CDC has outlined guidelines on those underlying conditions, which include heart disease, diabetes, obesity , chronic lung disease, liver disease and chronic kidney disease. The FDA last month approved Pfizer and Moderna booster shots only for certain people with weakened immune systems, such as cancer patients and transplant recipients.

The CDC has reviewed a series of studies looking at the overall effectiveness of vaccines between February and August 2021. The findings indicated that both Pfizer’s and Moderna’s two-shot vaccines wane over time, particularly for people 65 and older.

In its approval, the FDA followed the recommendation last week of an independent FDA advisory committee of experts. The FDA said it considered “the totality of the available scientific evidence and the deliberations of our advisory committee.” The FDA also said its authorization applies only to the Pfizer-BioNTech COVID-19 vaccine. About 22 million Americans are at least six months past their second dose of the Pfizer-BioNTech vaccine, says the CDC. About half of them are 65 and older.

Many of the millions of U.S. adults who received the Moderna and Johnson & Johnson vaccines are still waiting on approval to get their boosters. Both Moderna and Johnson & Johnson (more information below) plan to submit additional clinical trial data on booster shots to the FDA in coming weeks.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” said Acting FDA Commissioner Janet Woodcock, M.D. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

(Baptist Health South Florida is not providing booster shots, or third doses, at this time. Those who currently qualify for booster shots should obtain them at local retail pharmacies.)

Pfizer-BioNTech: Lower-Dose Vaccine for Kids Aged 5-11 Provides Robust, Safe Protection

A lower-dose version of the Pfizer-BioNTech vaccine provided “robust” protection for children ages 5 to 11 in a clinical trial, the companies announced.

Pfizer-BioNTech’s two-dose regimen, containing about one-third the dose provided to people 12 and older provided comparable antibodies those recorded in a previous study in people 16 to 25 years of age immunized the full doses.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA). U.S. public health officials anticipate approval of two-dose regimen for kids 5 to 11 by the end of October.

Children currently represent more than one in five new cases, and the highly contagious Delta variant has sent more children into hospitals, although severe illness from COVID-19 among kids is still rare. Pfizer-BioNTEch’s full-dose, two-shot regimen is currently approved for those 12 and older.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination,” said Albert Bourla, chairman and chief executive officer, Pfizer, in a news release. “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.”

Vaccine results from studies on children under 5 years of age are expected as soon as later this year, Pfizer and BioNTech said.

Johnson & Johnson: A 2nd Dose, or Booster, Provides 100% Protection Against ‘Severe/Critical COVID-19′

Johnson & Johnson this week released some clinical trial data on a second dose of its COVID-19 vaccine, with the pharmaceutical company asserting that a booster shot offers better protection for a longer period of time.

The one-dose Johnson & Johnson vaccine has trailed somewhat behind the 2-shot vaccines from Pfizer-BioNTech and Moderna in its efficacy against serious illness. J&J’s single shot is found to be about 74 percent effective against moderate and severe disease in the U.S.

The company stated in a news release that it’s second dose, administered two months after getting the first dose, provides up to 94 percent protection against “moderate to severe/critical) COVID-19,” and 100 percent protection against “severe/critical COVID-19.” 

Those who receive the J&J booster shot six months after the first shot are provided with a 12-fold increase in antibodies, the company added. The information released by the company this week is part of its Phase 3 trial.

Johnson & Johnson said it has provided the necessary data on its booster shot trial to the U.S. Food and Drug Administration (FDA) as part of the regulatory approval process.

“A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population,” said Paul Stoffels, M.D., chief scientific officer at Johnson & Johnson. “At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.”