FDA Greenlights ‘Mix and Match’ COVID Boosters + More

FDA Greenlights ‘Mix and Match’ COVID Boosters. Moderna, Johnson & Johnson Boosters Also Get Thumbs Up

MedPage Today reported:

The FDA authorized booster doses of Moderna and Johnson & Johnson‘s COVID-19 vaccines and also authorized a “mix and match” or heterologous approach to boosters for all three available vaccines (including Pfizer’s) in the indicated populations, the agency announced on Wednesday.

Ultimately, the FDA went with what was recommended by their advisory panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which voted for a half-dose Moderna booster in adults ages 65 and up, adults ages 18-64 at high risk of severe COVID, and adults 18-64 with frequent occupational and institutional exposure to SARS-CoV-2, at least 6 months after completing the primary series.

A booster of Johnson & Johnson vaccine is authorized for all adults ages 18 and up who received the Johnson & Johnson vaccine, at least 2 months after completion of the single-dose regimen.

U.S. CDC Advisers Weigh Moderna, J&J COVID Vaccine Boosters, Mix-and-Match Shots

Reuters reported:

A panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Thursday are considering several recommendations for rollout of COVID-19 vaccine boosters from Moderna Inc (MRNA.O) and Johnson & Johnson (JNJ.N), expected to pave the way for additional shots for millions of Americans.

The U.S. Food and Drug Administration on Wednesday authorized the booster doses, and said Americans can choose a different shot from their original inoculation.

The CDC is expected to sign off in the coming days on the recommendations of the panel for a rollout that health officials said could be confusing.

Michigan Woman’s Death Caused by Rare Johnson & Johnson COVID Vaccine Side Effect, Autopsy Report Says

MLive Michigan reported:

Though it took months to confirm it, Tatum Strieter-Byron knew from the start what no one seemed to want to believe.

The Johnson & Johnson COVID-19 vaccine brought about the April 21 death of her mother, 60-year-old Sandra Jacobs of Saline, a grandmother, a friend, an employee.

Jacobs died 13 days after she received the single-shot at a CVS pharmacy on April 8, just five days before federal health agencies temporarily paused the vaccine administration while they examined an unusual blood-clotting disorder.

UK Adds Nerve Disorder as Rare Side Effect of AstraZeneca COVID Vaccine

Reuters reported:

The UK drug regulator added an extremely rare nerve-damaging disorder, Guillain-Barré syndrome (GBS), as a very rare side effect of the AstraZeneca (AZN.L) COVID-19 vaccine, updates on the agency’s website showed on Thursday.

Medicines and Healthcare products Regulatory Agency’s (MHRA) decision comes after the European medicines agency added GBS as a possible side-effect last month. read more

NIH Admits Funding Gain-of-Function COVID Experiments; Gives EcoHealth Five Days to Report Data

ZeroHedge reported:

A top NIH official admitted in a Wednesday letter that the U.S.-funded so-called “gain-of-function” research in Wuhan, China — and that the U.S. nonprofit which conducted it, EcoHealth Alliance — led by the controversial Peter Daszak, “failed to report” that they had created a chimeric bat coronavirus which could infect humans.

In a letter addressed to Rep. James Comer (R-KY), NIH Principal Deputy Director Lawrence A. Tabak cites a “limited experiment” to determine whether “spike proteins from naturally occurring bat coronaviruses circulating in China were capable of binding to the human ACE2 receptor in a mouse model.”

According to the letter, humanized mice infected with the modified bat virus “became sicker” than those exposed to an unmodified version of the same bat coronavirus. Daszak failed to report this finding, and has been given five days to submit “any and all unpublished data from the experiments and world conducted” under the NIH grant.

Sweden Extends Pause of Moderna Vaccine for Younger Age Groups

Reuters reported:

Sweden has extended the pause of Moderna‘s (MRNA.O) COVID-19 vaccine for people aged 30 and younger due to rare heart-related side effects, the public health agency said on Thursday.

The health agency said earlier in October that data pointed to an increase of myocarditis and pericarditis among youths and young adults vaccinated with Moderna vaccine Spikevax, and paused the use for all born 1991 or later.

The health agency also said it was time to cease wide-scale testing and will remove the recommendation for testing for those who are fully vaccinated, even if they are displaying symptoms.

Half Doses, Third Doses, Kids’ Doses: COVID Vaccine Delivery Goes Next-Level Difficult

STAT News reported:

The U.S. COVID-19 vaccine rollout is about to get a lot more complicated.

But with boosters becoming available for select groups of people, and a lower-dose shot for young children expected shortly, the campaign is moving from a simple set of instructions to more of a messy flow chart for people organizing and delivering the jabs.

Two different boosters for two different adult populations means plenty of room for mixups.

Why Team Biden Is Purposely Scaring Folks About Kids and COVID

New York Post reported:

The papers and newscasts on Wednesday morning were filled with stories about just how incredibly focused the Biden people are on the rollout of the vaccinations of American kids from the ages of 5 to 11 (once the science guys give absolutely final approval).

They’re shortening needles to make them less scary for kids! They’re developing a whole new model that doesn’t involve mass vaccination sites!

There’s a reason for the intensity and omnipresence of this specific PR rollout. The Bidenites are desperate to change the focus of the national political conversation.

How COVID Changed American Cities, in 5 Charts

Politico reported:

At the start of the pandemic, the familiar hustle and bustle of cities across the nation quieted. Los Angeles’ infamous traffic dwindled and New York’s crowded subway stations emptied. In the months since, some residents and workers have returned, but not all.

These charts illustrate some of the changes brought on by COVID-19, and how the life of our cities is evolving.

New COVID Variant Emerges, Doctors Call It ‘Delta Plus’

WISH TV reported:

A new coronavirus variant has emerged in places such as Europe and Canada, and scientists worry it spreads even faster than the Delta variant. They have dubbed the new mutation ‘Delta plus’ because it’s said to be 10% more transmissible than the original Delta strain currently dominating the globe.

Health authorities are particularly concerned because Delta plus has evolved in a way that allows it to better infect human cells.

What Will the COVID Vaccine Rollout for Kids 5-11 Look Like in Mass.?

NBC Boston reported:

Beacon Hill lawmakers will get a look Thursday morning at Massachusetts’ plan to vaccinate children. This comes as kids between 5 and 11 could become eligible for the vaccine as early as next month; roughly 515,000 Massachusetts children fall into this group.

The White House is preparing for the rollout as everyone awaits FDA and CDC approval.

Boston pediatrician Robin Riseberg says she’s constantly reassuring anxious parents that the vaccine is safe and effective. “They’re nervous about side effects,” said Dr. Riseberg, founder of Boston Community Pediatrics.

The post FDA Greenlights ‘Mix and Match’ COVID Boosters + More appeared first on Children's Health Defense.

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