November 29, 2021 by John Fernandez
Roundup: ‘Mixing and Matching’ Boosters Approved for Pfizer, Moderna and J&J Shots; Hospitalization Risk for Unvaccinated at 12 Times Higher; and More
FDA Approves “Mixing and Matching” Pfizer, Moderna and J&J Booster Shots
The U.S. Food and Drug Administration (FDA) has authorized the “mixing and matching” of booster doses for the currently available COVID-19 vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson.
“A single booster dose of any of the available COVID-19 vaccines may be administered … following completion of primary vaccination with a different available COVID-19 vaccine,” the FDA stated. However, those eligible for “mixing and matching” boosters are the same as those eligible for a booster dose of the vaccine used for primary vaccination.
The highly anticipated mix-and-match authorization by the FDA was accompanied by the final authorization of the Moderna and Johnson & Johnson booster doses. The FDA concluded that clinical data showed both the Moderna and J&J boosters were safe and effective. Last month, the regulatory agency approved the booster shot from Pfizer-BioNTech.
All three booster doses have been authorized for individuals who are:
- 65 years of age and older;
- 18 through 64 years of age with underlying health issues that put them at high risk of severe COVID-19;
- 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.
When it comes to “mixing and matching,” you must keep to the required minimum of time allowed between the final regular dose and the booster dose. The booster shots from Pfizer and Moderna should be administered at least six months after completion of the primary series of the vaccine, the FDA said. The Johnson & Johnson booster should be administered at least two months after completion of the single-dose primary regimen.
Recipients of the Pfizer or Moderna primary vaccinations can switch at least six months after the second shot. Those who initially received the single-shot Johnson & Johnson COVID-19 vaccine may receive a single booster dose of same J&J vaccine, a booster dose of the Moderna vaccine or of the Pfizer-BioNTech vaccine — at least two months after receiving their Johnson & Johnson primary vaccination, stated the FDA.
An advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) is weighing the evidence for COVID boosters from Moderna and Johnson & Johnson, and the “mix and match” strategy. The CDC usually follows the vaccine authorizations by the FDA, and the CDC is expected to approve all three boosters, as well as mixing and matching.
CDC Data Now Show Rates of Hospitalizations, Deaths and Cases Among Unvaccinated vs. Vaccinated
The U.S. Centers for Disease Control and Prevention has started reporting COVID-19 cases and deaths according to vaccination status — focusing on sharp differences in outcomes among those who haven’t received one of the three available vaccines in the U.S. from Pfizer-BioNTech, Moderna and Johnson & Johnson.
By reviewing the newly organized CDC data, readers can also determine which vaccine product is producing the best outcomes on a weekly basis. The most recent data from the CDC finds that the risk of dying from COVID-19 was 11 times higher among unvaccinated adults, compared to fully vaccinated adults in the U.S.
The risk of being hospitalized, among those 18 and older, was nearly 12 times higher for unvaccinated adults than fully vaccinated adults.
“Although weekly rates can vary, the cumulative rate of COVID-19-associated hospitalizations in unvaccinated adults ages 18–49 years was about 14-times higher than fully vaccinated adults aged 18–49 years,” the CDC added.
Overall, unvaccinated adults were at a six times higher risk of testing positive for COVID-19. The CDC data is not fully representative, because only some states and local jurisdictions are publishing COVID infection rates, and death and hospitalization rates by vaccination status. The CDC continues to work with health departments to link case data with available immunization information for the agency’s own analysis.
The latest data from August 29 to September 4 indicates that less than one vaccinated person per 100,000 had died the previous week, compared with more than nine unvaccinated individuals per 100,000.
By the last week of August, according to the most recent data made public, the CDC states that COVID-19 death rates among unvaccinated adults were about 30 percent lower than they were in the first week of the month, dropping from a rate of 13 deaths per 100,000 people to about 9 deaths per 100,000 people.
In comparison, the risk for fully vaccinated adults has never been higher than 1.2 deaths per 100,000 since April.
The risk of cases and deaths have dropped overall over the past several weeks, but the CDC data finds that the rate of hospitalizations among unvaccinated adults continued to climb throughout August, up more than 80 percent.
Biden Administration Plans COVID-19 Vaccination Rollout for Kids Ages 5-11 When Authorized by FDA, CDC
In anticipation of approvals from U.S. regulatory agencies over the next two weeks, the Biden Administration has announced a plan to ensure that vaccines for children ages 5-11 are “quickly distributed and made conveniently and equitably available to families across the country.”
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are expected to approve a lower-dose version of the Pfizer-BioNTech vaccine for children ages 5-11. Currently, the full-dose Pfizer vaccine is available for persons aged 12 and older.
The federal government said it has procured enough vaccines for the country’s 28 million children ages 5-11, pending the authorizations.
The Administration said it will make vaccination “accessible and conveniently located” for families across the U.S., including locations such as clinics at doctors’ offices, pediatric hospitals, pharmacies, community health centers, and school- and community-based sites.
“Millions of adolescents ages 12-17 have been safely vaccinated, and we know vaccines work,” the Biden Administration stated in a news release this week. “Fully vaccinated individuals are 10 times less likely to be hospitalized with COVID-19 and have a high degree of protection, including against the Delta variant. The consequences of a pediatric COVID-19 case can be serious and potentially last months.”
A key component of the Administration’s planning is working closely with state and local leaders to make sure “they are prepared to distribute and administer vaccines,” the news release said.
The Administration said it will make vaccinations available at doctors’ offices across the country — more than 25,000 offices pediatricians and primary care physicians. “These providers will play a critical role in the nationwide effort to get children vaccinated,” the White House statement said.
The Biden Administration said it is also partnering with the Children’s Hospital Association, representing more than 100 children’s hospital systems across the country, to set up vaccination sites in November and December.