FDA: Monovalent Pfizer and Moderna COVID-19 Vaccines Are No Longer Authorized, New Protocols Announced

In a press release on Tuesday, the FDA has declared the monovalent Pfizer and Modena mRNA Covid-19 vaccines are no “longer authorized for use in the United States.”

The decision was made through a recent amendment to the Emergency Use Authorizations of the Moderna and Pfizer Covid-19 bivalent vaccines.

In the amendment, the FDA ruled the bivalent Moderna and Pfizer Covid-19 vaccines will be used for all doses and monovalent doses (targeted original strain) will no longer be authorized.

The FDA claims the decision was made in order to simplify the vaccine process, but many people who have already received the monovalent Covid-19 vaccine are questioning why the FDA is making the decision now.

Today, FDA amended the EUAs of the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. https://t.co/Cd74KB3n9p
What you need to know. 🧵👇 pic.twitter.com/9394LP1HvR

— U.S. FDA (@US_FDA) April 18, 2023

Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.

— U.S. FDA (@US_FDA) April 18, 2023

Per The FDA:

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals.

This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.

Most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose. The FDA intends to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June.

The sudden decision caught the attention of James O’Keefe who is now asking FDA whistleblowers to come forward.

Can someone from the FDA please tell me what’s going on here? This email address is being protected from spambots. You need JavaScript enabled to view it. https://t.co/YfyLeJyWNn

— James O'Keefe (@JamesOKeefeIII) April 18, 2023

 

The post FDA: Monovalent Pfizer and Moderna COVID-19 Vaccines Are No Longer Authorized, New Protocols Announced appeared first on The Gateway Pundit.

US Senate Releases Report on Origins of COVID – Continues to Give China a Break on One Key Point

A report from the GOP US Senators states that the origin of COVID was in Wuhan, China but the Senate gives China a break. 

ABC shared:

A new report from Senate Republicans doubles down on the theory that COVID-19 emerged from an accidental lab leak in Wuhan — and possibly, even more than one leak.

While their investigation concedes that “both hypotheses are plausible,” the nearly 300-page document released by the minority on the Senate health subcommittee makes a circumstantial case that the “preponderance of circumstantial evidence” points to “an unintentional research-related incident” — an undetected aerosol leak — likely at the Wuhan Institute of Virology (WIV), as the first spark which would ultimately ignite the pandemic.

The WIV has long been known for not just its extensive research on bat coronaviruses, but also poor biosafety conditions while dealing with risky contagion samples which need proper containment, investigators wrote.

The document says an initial leak may have occurred “sometime before September 2019” and began circulating in Wuhan. Then, once WIV and Chinese government authorities realized what had happened, officials scrambled to quickly and quietly develop a vaccine that could be deployed to contain the outbreak — all before the world could learn the truth, according to the authors.

That rush to develop a vaccine may have led to a second accidental lab leak — one which, in turn, would lead to the global pandemic, the investigators believe.

When the Senate says that this release of COVID was an accident they give China a huge break.  This is a key point. 

Kansas Senator Roger Marshall who is also a physician discussed the report on FOX News yesterday:

After more than two years of research, Sen. Marshall revealed on “Mornings with Maria” Tuesday that a “preponderance of evidence” points to two lab leaks in China as the cause of the global pandemic.

“This is big. It is a bombshell that the preponderance of evidence shows that there were two lab leaks,” Sen. Marshall said. “If we had a scale in front of us and we put all the evidence on one side that supports a natural spillover, the other for the lab origin of this, I think that 95% of that evidence is on the lab origin.”

Watch the latest video at foxbusiness.com

Here is the document:

Mwg Fdr Document 04-11-23 Embargoed (1) by Jim Hoft on Scribd

This report was discussed with Natalie Winters on the War Room.  Ms. Winters made an observation at the end of her interview where she challenged the report’s assertion that this was an accident.  We may never know the answer to this but China had a reason to drop COVID because they were getting crushed economically by President Trump’s actions with trade and assistance on a trade agreement.

The post US Senate Releases Report on Origins of COVID – Continues to Give China a Break on One Key Point appeared first on The Gateway Pundit.

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