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FDA votes against Pfizer booster for general public + Grow & eat your own vaccines?

#1
C C Offline
FDA panel votes to recommend third shot for some Pfizer vaccine recipients (65 & older)
https://www.cnet.com/health/fda-panel-vo...ecipients/

RELEASE: During a day-long meeting Friday, an advisory panel to the Food and Drug Administration voted against recommending a booster dose of Pfizer's COVID-19 vaccine for everyone age 16 and older who received the two-dose regimen.

However, in a subsequent vote, the committee voted that adults age 65 and older and people at risk of severe COVID-19 should get an extra dose because the known benefits outweigh the known and unknown risks.

The committee voted 16-2 against a third dose for the general public following Pfizer's two-dose regimen. Members who voted "no" cited a lack of evidence that the benefits of a third dose for most people would outweigh the unknown risks of another shot. Some committee members pointed out the risk of myocarditis, a rare side effect which is mostly seen in younger men.

The Biden administration had hoped the booster plan for Pfizer recipients would begin as early as Sept. 20, but that depended on approval from the FDA and the Centers for Disease Control and Prevention.

The vote by the FDA panel isn't binding, but the agency will likely accept the recommendation and make a decision by early next week, The New York Times reported. When the FDA does make it official, it's possible the booster recommendation will extend to health care workers, teachers or other people whose jobs put them at risk of COVID-19 infection, or those who have "occupational exposure," per the advisory committee.

The FDA fully approved Pfizer's COVID-19 vaccine last month and has already signed off on an extra shot for some immunocompromised people, including solid organ transplant recipients and people receiving treatment for cancers of the blood.

Friday's meeting by the FDA's advisory committee comes a few weeks after it was announced that two FDA regulators will step down this fall, reportedly because they're in disagreement with the US plan to get adults a COVID-19 booster eight months after their second shot.


Grow and eat your own vaccines?
https://news.ucr.edu/articles/2021/09/16...n-vaccines

RELEASE: The future of vaccines may look more like eating a salad than getting a shot in the arm. UC Riverside scientists are studying whether they can turn edible plants like lettuce into mRNA vaccine factories.

Messenger RNA or mRNA technology, used in COVID-19 vaccines, works by teaching our cells to recognize and protect us against infectious diseases.

One of the challenges with this new technology is that it must be kept cold to maintain stability during transport and storage. If this new project is successful, plant-based mRNA vaccines — which can be eaten — could overcome this challenge with the ability to be stored at room temperature.

The project’s goals, made possible by a $500,000 grant from the National Science Foundation, are threefold: showing that DNA containing the mRNA vaccines can be successfully delivered into the part of plant cells where it will replicate, demonstrating the plants can produce enough mRNA to rival a traditional shot, and finally, determining the right dosage. 

“Ideally, a single plant would produce enough mRNA to vaccinate a single person,” said Juan Pablo Giraldo, an associate professor in UCR’s Department of Botany and Plant Sciences who is leading the research, done in collaboration with scientists from UC San Diego and Carnegie Mellon University. “We are testing this approach with spinach and lettuce and have long-term goals of people growing it in their own gardens,” Giraldo said. “Farmers could also eventually grow entire fields of it.”

Key to making this work are chloroplasts — small organs in plant cells that convert sunlight into energy the plant can use. “They’re tiny, solar-powered factories that produce sugar and other molecules which allow the plant to grow,” Giraldo said. “They’re also an untapped source for making desirable molecules.”

In the past, Giraldo has shown that it is possible for chloroplasts to express genes that aren’t naturally part of the plant. He and his colleagues did this by sending foreign genetic material into plant cells inside a protective casing. Determining the optimal properties of these casings for delivery into plant cells is a specialty of Giraldo’s laboratory.

For this project Giraldo teamed up with Nicole Steinmetz, a UC San Diego professor of nanoengineering, to utilize nanotechnologies engineered by her team that will deliver genetic material to the chloroplasts. "Our idea is to repurpose naturally occurring nanoparticles, namely plant viruses, for gene delivery to the plants," Steinmetz said. "Some engineering goes into this to make the nanoparticles go to the chloroplasts and also to render them non-infectious toward the plants."

For Giraldo, the chance to develop this idea with mRNA is the culmination of a dream. “One of the reasons I started working in nanotechnology was so I could apply it to plants and create new technology solutions. Not just for food, but for high-value products as well, like pharmaceuticals,” Giraldo said.

He is also co-leading a related project using nanomaterials to deliver nitrogen, a fertilizer, directly to chloroplasts, where plants need it most. Nitrogen is limited in the environment, but plants need it to grow. Most farmers apply nitrogen to the soil. As a result, roughly half of it ends up in groundwater, contaminating waterways, causing algae blooms, and interacting with other organisms. It also produces nitrous oxide, another pollutant.

This alternative approach would get nitrogen into the chloroplasts through the leaves and control its release, a much more efficient mode of application that could help farmers and improve the environment.

The National Science Foundation has granted Giraldo and his colleagues $1.6 million to develop this targeted nitrogen delivery technology. “I’m very excited about all of this research,” Giraldo said. “I think it could have a huge impact on peoples’ lives.”
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#2
Leigha Offline
Quote:Friday's meeting by the FDA's advisory committee comes a few weeks after it was announced that two FDA regulators will step down this fall, reportedly because they're in disagreement with the US plan to get adults a COVID-19 booster eight months after their second shot.

So, is it safe to assume that the Biden administration is putting pressure on the CDC to push the booster shot message? There are so many mixed messages, lately - which is more harmful, to recommend boosters or not? It's disturbing to see the FDA and CDC at odds with each other, when they should be working together.
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#3
C C Offline
(Sep 18, 2021 03:50 AM)Leigha Wrote:
Quote:Friday's meeting by the FDA's advisory committee comes a few weeks after it was announced that two FDA regulators will step down this fall, reportedly because they're in disagreement with the US plan to get adults a COVID-19 booster eight months after their second shot.

So, is it safe to assume that the Biden administration is putting pressure on the CDC to push the booster shot message? There are so many mixed messages, lately - which is more harmful, to recommend boosters or not? It's disturbing to see the FDA and CDC at odds with each other, when they should be working together.

The FDA doesn't have to follow the recommendations of the advisory panels, but it probably will when it makes a decision in the next few days.

Biden's premature booster plans were supposedly to give vaccine providers time to prepare, which as it turns out may be needed. If those over 65, medical workers, and other high-risk cases will be cleared at some point to receive shots. In that respect, it apparently is going to take place.

The agencies are going to wait for additional data about waning antibody levels before making a decision about the rest of the population. Receiving a third shot too soon could result in problems for a fraction of younger adults.

This actually kind of echoes the original vaccinations in the early part of the year, where the same vulnerable groups (over 65, hospital staff, etc) received the initial shots first. The time gap will probably be much longer this time, though.

A lot of this panel's discussions were targeted on Israel's booster shot program, where the latter's experts related that their medical facilities would have been overwhelmed without a third dose rollout in late July. Some members pointed out, however, that "Israel’s experience with COVID and the Pfizer vaccine differed from that of the United States".
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#4
Leigha Offline
(Sep 18, 2021 05:18 AM)C C Wrote:
(Sep 18, 2021 03:50 AM)Leigha Wrote:
Quote:Friday's meeting by the FDA's advisory committee comes a few weeks after it was announced that two FDA regulators will step down this fall, reportedly because they're in disagreement with the US plan to get adults a COVID-19 booster eight months after their second shot.

So, is it safe to assume that the Biden administration is putting pressure on the CDC to push the booster shot message? There are so many mixed messages, lately - which is more harmful, to recommend boosters or not? It's disturbing to see the FDA and CDC at odds with each other, when they should be working together.

The FDA doesn't have to follow the recommendations of the advisory panels, but it probably will when it makes a decision in the next few days.

Biden's premature booster plans were supposedly to give vaccine providers time to prepare, which as it turns out may be needed. If those over 65, medical workers, and other high-risk cases will be cleared at some point to receive shots. In that respect, it apparently is going to take place.

The agencies are going to wait for additional data about waning antibody levels before making a decision about the rest of the population. Receiving a third shot too soon could result in problems for a fraction of younger adults.

This actually kind of echoes the original vaccinations in the early part of the year, where the same vulnerable groups (over 65, hospital staff, etc) received the initial shots first. The time gap will probably be much longer this time, though.

A lot of this panel's discussions were targeted on Israel's booster shot program, where the latter's experts related that their medical facilities would have been overwhelmed without a third dose rollout in late July. Some members pointed out, however, that "Israel’s experience with COVID and the Pfizer vaccine differed from that of the United States".

There are other articles out there suggesting that the mRNA vaccines could ''last'' up to three to four years. Just too much conflicting information. Guess time will tell.
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