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Monkeypox vaccine maker pushes back at FDA plan to give smaller doses

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WHAT YOU NEED TO KNOW:


  • The manufacturer of the only FDA-approved monkeypox vaccines is raising concerns about the United States’ plan to split doses to stretch the nation’s limited supply.
  • The Biden administration announced new measures to share one vaccine dose among “up to five” people.
  • There are more than 10,000 confirmed cases of monkeypox in the U.S. – the world’s largest outbreak – and demand for the vaccine far exceeds supply.

The manufacturer of the monkeypox vaccine is raising concerns after the Biden Administration’s plans to split doses and change how they are administered to stretch the nation’s limited supply

Paul Chaplin, CEO of Bavarian Nordic, which manufactures the Jynneos vaccine, wrote a letter to Health and Human Services Secretary Xavier Becerra and FDA Commissioner Robert M. Califf to express their concerns. The letter details “reservations” the company has about the dose-sharing strategy “due to the very limited safety data available.”

In the letter, shared by The Washington Post, Chaplin said “it would have been prudent” to conduct studies on the approach that could provide more safety information.

“We have been inundated with calls from U.S. state government officials with questions and concerns regarding the ID administration,” he wrote. “We will of course align our responses with our colleagues at the CDC, but we believe this alignment would have been better served before any announcement.”

On Wednesday, Becerra addressed the concerns but noted that the Biden Administration is confident in the vaccine strategy.

“We’ve had conversations with them about this, and so has FDA,” Becerra said. “We wouldn’t have moved forward unless we thought it was safe and effective, and if FDA hadn’t dotted its I’s and crossed its T’s.”

The HHS and FDA announced the plan Tuesday. They said​ that the emergency declaration would allow health care providers to administer one-fifth of the current dose of the monkeypox vaccine into the skin instead of a full dose into underlying fat.

A small dose can be used with an intradermal injection because the vaccine is “staying in the skin; you’re not going through the skin,” Dr. Daniel Griffin, an infectious disease specialist at Columbia University said.

The procedure had been used for flu and rabies vaccines. It produces an immune response in the skin. “The skin has special cells that are very good at helping a vaccine stimulate the body’s immune system,” epidemiologist Dr. Jay Varma told CNN. “They live in the skin, and they’re better at teaching the immune system what they need to respond to,” he added.

Jynneos, the only FDA-approved monkeypox vaccine, is currently administered in two doses under the skin.

According to the CDC, the U.S. has currently more than 10,000 confirmed cases of monkeypox.

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Source: The Hill

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4 Comments

4 Comments

  1. Sean Rickman

    August 12, 2022 at 6:46 pm

    I hope that the”donkey pox”vaccine doesn’t cause the problems that the phizer poison caused.I can tell you positively that my wife and I were healthy senior citizens until about six months ago,about a month after phizer,loss of concentration,short term memory loss,fatigue,so thank you.you totally corrupt demonRATS for pushing this garbage.I really blame the”twits”that are controlling sloppy joey and the rest of your governments agencies.

  2. David

    August 12, 2022 at 7:28 pm

    I can say that members of my own family bought the governments scare tactics and now have chronic fatigue syndrome. My sister in law was forced to get the vaccine as a healthcare worker and now has fibromyalgia full blown that had been under control for years. Now she is very ill. This covid virus that Fauci joked about cooking up in his kitchen is an absolute fraud. A very rich fraud that made hundreds of millions over the years peddling his vaccines. I believe he started with AZT that was the only drug allowed for use in aids patients. Anyone who took it was dead in six months. It was more toxic than the aids virus itself. This guy has been a fraud since then. Oh it was discontinued when they realized it was more deadly than the aids virus. Why stop there? Now his killer drug is the covid shot. It will be a cold day in hell when the US government makes me take any shot I don’t consent to. I call it a population control measure that this nasty virus was unleashed on us by Fauci’s government funded gain of function research. Fauci would be in jail in a perfect world. They will lie, lie, lie, what an accurate statement. Trump is always right in the end. He just gets ridiculed by idiot libs before the truth comes out. Same ol. Think for yourselves people!

  3. mike

    August 13, 2022 at 9:07 am

    Here’s what the company announced on Friday. Many of the 1.9 million doses are being held by the company until the U.S. government requests them.

    “With the previous order from BARDA for 1.4 million doses of liquid-frozen JYNNEOS, awarded in 2020, this order will bring the total U.S. inventory of the vaccine to nearly 2 million doses.”

  4. Patty

    August 15, 2022 at 1:35 am

    How about mandating them to abstain from their perverted sex orgies? Oh no! They can’t do that, that would be homophobia! This is one of God’s plagues on the abomination of sodomy! There is more to come if they don’t clean up their act. God never lies! If you insist on having gay sex, it is on YOU! Your choice!

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