Coronavirus vaccines: Why are some countries recommending single dose for teens, young adults?

Business

Fox News 12 October, 2021 - 06:39am

ROME — Moderna has no plans to share the recipe for its COVID-19 vaccine because executives have concluded that scaling up the company's own production is the best way to increase the global supply, the company's chairman said Monday.

In an interview with The Associated Press, Noubar Afeyan also reiterated a pledge Moderna made a year ago not to enforce patent infringement on anyone else making a coronavirus vaccine during the pandemic.

"We didn't have to do that," Afeyan said. "We think that was the responsible thing to do." He added: "We want that to be helping the world."

The United Nations health agency has pressed Moderna to share its vaccine formula. Afeyan said the company analyzed whether it would be better to share the messenger RNA technology and determined that it could expand production and deliver billions of additional doses in 2022.

"Within the next six to nine months, the most reliable way to make high-quality vaccines and in an efficient way is going to be if we make them," Afeyan said. Asked about appeals from the World Health Organization and others, he contended that such pleas assumed "that we couldn't get enough capacity, but in fact we know we can."

Moderna "went from zero production to having 1 billion doses in less than a year," Afeyan said, referring to the Massachusetts-based company's sprint to develop the vaccine and produce it in large quantities. "And we think we will be able to go from 1 to 3 billion" in 2022.

The COVID-19 vaccine is Moderna's only commercial product. The company announced plans last week to open a vaccine plant somewhere in Africa. Afeyan said he hopes a decision will be made soon on an exact location. Still, it could take years to get the plant up and running.

Afeyan spoke on the last full day of a visit to Italy in which he met Pope Francis, who has appealed for universal vaccine access. He also appeared in Venice to promote a humanitarian prize initiative.

Read full article at Fox News

Expansion of Vaccine Booster Programme

govsg 12 October, 2021 - 09:31pm

This material may not be published, broadcast, rewritten, or redistributed. ©2021 FOX News Network, LLC. All rights reserved. Quotes displayed in real-time or delayed by at least 15 minutes. Market data provided by Factset. Powered and implemented by FactSet Digital Solutions. Legal Statement. Mutual Fund and ETF data provided by Refinitiv Lipper.

Dr. Stephen Hoge, Moderna's president, says COVID-19 vaccines are 'really effective,' but notes that the Delta variant 'poses a substantial threat to all of the vaccines' and the durability of immunity.

The U.S. Food and Drug Administration reiterated its stance that the benefits of Moderna’s COVID-19 vaccine outweigh its risks on Friday after several Nordic countries began restricting its use for certain age groups due to concerns about a rare heart-related side effect.

The FDA responded after health officials in Finland said Thursday that males under age 30 should not receive the Moderna vaccine due to a slightly higher risk of developing myocarditis, an inflammation of the heart. A day earlier, Sweden said it would pause use of Moderna’s vaccine for people under 30, while Denmark paused use for people under 18 and Norway recommended people receive the Pfizer vaccine.

"The FDA is aware of these data. At this time, FDA continues to find that the known and potential benefits of vaccination outweigh the known and potential risks for the Moderna COVID-19 Vaccine," an FDA official said in a statement.

The Nordic countries based their decision on an unpublished study set to be reviewed by the European Medicines Agency’s adverse reaction committee. Sweden’s public health agency said the study found "an increased risk of side effects such as inflammation of the heart muscle or the pericardium," though it noted the risk was "very small."

The Moderna COVID-19 vaccine and other versions have been found to be safe and highly effective against the risk of hospitalization or death due to coronavirus. Moderna said it was "aware of the very rare occurrence of myocarditis and/or pericarditis following administration of mRNA vaccines against COVID-19."

"These are typically mild cases and individuals tend to recover within a short time following standard treatment and rest. The risk of myocarditis is substantially increased for those who contract COVID-19, and vaccination is the best way to protect against this," the company said in a statement.

The FDA granted full approval for Pfizer’s COVID-19 vaccine in August. Moderna’s application for full approval is still pending.

Stay up-to-date on the biggest health and wellness news with our weekly recap.

You've successfully subscribed to this newsletter!

This material may not be published, broadcast, rewritten, or redistributed. ©2021 FOX News Network, LLC. All rights reserved. Quotes displayed in real-time or delayed by at least 15 minutes. Market data provided by Factset. Powered and implemented by FactSet Digital Solutions. Legal Statement. Mutual Fund and ETF data provided by Refinitiv Lipper.

U.S. FDA staff says Moderna did not meet all criteria for COVID-19 boosters

Big News Network 12 October, 2021 - 09:31pm

(Reuters) -Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong.

FDA staff said in documents that data for Moderna's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high.

The documents were released ahead of a meeting later this week of the FDA's outside expert advisers to discuss booster doses of the vaccine.

The FDA typically follows the advice of its experts, but is not bound to do so. A panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to discuss specific recommendations on who can receive the boosters, if the FDA authorizes them.

"There was boosting, sure. Was it enough boosting? Who knows? There’s no standard amount of boosting that is known to be needed, and nor is it clear how much boosting happened in the study,” John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York, said in an email.

Moderna is seeking authorization for a 50-microgram booster dose, half the strength of the original vaccine given in two shots about four weeks apart.

The company has asked regulators to clear a third round of shots for adults aged 65 and over, as well as for high-risk individuals, similar to the authorization gained by rivals Pfizer Inc and German partner BioNTech for their mRNA vaccine.

President Joe Biden's administration announced plans earlier this year to roll out booster doses for most adults, but some FDA scientists later said in an article in journal The Lancet that there was not enough evidence to support boosters for all.

Data on the need for boosters has largely come from Israel, which rolled out the additional shots of the Pfizer/BioNTech vaccine to large swaths of its population, and has provided details on the effectiveness of that effort to U.S. advisers.

No similar real-world study populations exist for the Moderna or Johnson & Johnson vaccines.

The evidence for Moderna's booster appears to have "a lot of holes," said Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in La Jolla, California, noting that the data provided was limited and offers no insight into how the boosters actually perform in people.

"That is fairly short of what Pfizer had from Israel, where they had the full restoration of the vaccine effectiveness from the booster," Topol said.

The FDA's advisers will also consider booster doses for J&J's single-dose vaccine on Friday. The FDA has not yet released its briefing documents on those shots.

J&J has asked the FDA to authorize a booster at least two months after the initial shot. It said data suggests high-risk adults should receive boosters earlier, but that lower-risk individuals could benefit from waiting at least six months for their second shot.

(Reporting by Michael Erman in New Jersey, Julie Steenhuyen in Chicago and Manas Mishra in Bengaluru; Editing by Arun Koyyur and Bill Berkrot)

Moderna, J&J COVID-19 vaccines: FDA advisory panel to weigh boosters this week

FOX 5 NY 12 October, 2021 - 12:38pm

With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it's their turn.

Federal regulators begin tackling that question this week.

On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra doses of the two vaccines should be dispensed and, if so, who should get them and when. The final go-ahead is not expected for at least another week.

After the FDA advisers give their recommendation, the agency itself will make a decision on whether to authorize boosters. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get them. Its decision is subject to approval by the CDC director.

RELATED: New Merck Covid pill reduces hospitalizations, deaths by 50 percent, drug-maker says

The process is meant to bolster public confidence in the vaccines. But it has already led to conflicts among experts and agencies — and documents the FDA released Tuesday suggest this week’s decisions will be equally difficult.

In one earlier vaccine dispute, the CDC's advisory panel last month backed Pfizer boosters at the six-month point for older Americans, nursing home residents and people with underlying health problems. But CDC Director Dr. Rochelle Walensky overruled her advisers and decided boosters should also be offered to those with high-risk jobs such as teachers and health care workers, adding tens of millions more Americans to the list.

Some health experts fear the back-and-forth deliberations are muddling the public effort to persuade the unvaccinated to get their first shots. They worry that the talk of boosters will lead people to wrongly doubt the effectiveness of the vaccines in the first place.

When the FDA's panel meets to review the Moderna and J&J vaccines, experts will discuss whether a third Moderna shot should contain just half the original dose and what’s the best timing for a second shot of the single-dose J&J vaccine.

RELATED: COVID vaccines: The difference between a 3rd shot and a booster

The panel will also look into the safety and effectiveness of mixing-and-matching different brands of vaccine, something regulators have not endorsed so far.

An estimated 103 million Americans are fully vaccinated with Pfizer’s formula, 69 million with Moderna’s and 15 million with J&J’s, according to the CDC. Regulators took up the question of Pfizer boosters first because the company submitted its data ahead of the other vaccine makers.

Tim Anderson, a U.S. history teacher at a high school outside Louisville, Kentucky, already had his two Moderna shots months before he came down with COVID-19 in August. While his symptoms hit him "like a sledgehammer," he is convinced that the inoculation saved him and his girlfriend from the more severe effects of the disease.

The two are now awaiting clearance of a Moderna booster shot.

RELATED: Moderna says it has no plans to share COVID-19 vaccine formula

"Until we can build up enough immunity within our own self and, you know, as a group of humans, I’m willing to do what I need to do," Anderson, 58, said.

The FDA meetings come as U.S. vaccinations have climbed back above 1 million per day on average, an increase of more than 50% over the past two weeks. The rise has been driven mainly by Pfizer boosters and employer vaccine mandates.

While the FDA and CDC so far have endorsed Pfizer boosters for specific groups only, Biden administration officials, including Dr. Anthony Fauci, have suggested that extra shots will eventually be recommended for most Americans.

In a new review of Moderna's data, the FDA did not indicate Tuesday if it was leaning toward clearing the company's booster. It said vaccines used in the U.S. still provide protection, and it raised questions about some of Moderna's data.

RELATED: NIH: Moderna COVID-19 vaccine generates long-lasting immune memory cells

The two initial Moderna shots contain 100 micrograms of vaccine each. But the drugmaker says 50 micrograms ought to be enough for a booster for healthy people.

A company study of 344 people gave them a 50-microgram shot six months after their second dose, and levels of virus-fighting antibodies jumped. Moderna said the booster even triggered a 42-fold rise in antibodies able to target the extra-contagious delta variant.

Side effects were similar to the fevers and aches that Moderna recipients commonly experience after their second regular shot, the company said.

As for people who got the J&J vaccine, the company submitted data to the FDA for different options: a booster shot at two months or at six months. The company said in its FDA submission that a six-month booster is recommended but that a second dose could be given at two months in some situations.

RELATED: FDA says Moderna vaccine's benefits outweigh risks after Nordic countries limit use

J&J released data in September showing that a booster given at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not disclosed patient data on a six-month booster, but early measures of virus-fighting antibodies suggest it provides even higher protection.

Even without a booster, J&J says, its vaccine remains about 80% effective at preventing COVID-19 hospitalizations in the U.S.

Scientists emphasize that all three vaccines used in the U.S. still offer strong protection against severe disease and death from COVID-19. The issue is how quickly, and how much, protection against milder infection may wane.

In one recent study, researchers compared about 14,000 people who had gotten their first Moderna dose a year ago with 11,000 vaccinated eight months ago. As the delta variant surged in July and August, the more recently vaccinated group had a 36% lower rate of "breakthrough" infections compared with those vaccinated longer ago.

This material may not be published, broadcast, rewritten, or redistributed. ©2021 FOX Television Stations

COVID-19 Update from PCPHE for October 6th, 2021 - The Prowers Journal

The Prowers Journal 11 October, 2021 - 05:32pm

The Prowers County Test Positivity Rate as of October 6, 2021 is 4.9% out of a goal of 5%.  This is down from 9.22% post from last week.  There have been 33 cases in the county in the past seven days with one person having been vaccinated and 65 cases of COVID-19 in the past 14 days.  The cumulative number of cases is at 1,513 with 109 hospitalizations and 28 deaths, up one from the last report.  The 30-39 age bracket continues to post the highest number of cases at 225, followed by 20-29 and 60-69 age groups at just over 200 cases each.

This week Prowers County Department of Health and Environment are offering ALL 3 vaccine types Friday, 10/08/21 from 9:00-11:00AM and 2:00-4:00PM

o Only for those who received Pfizer vaccine as their primary series (for the first 2 doses).

o People 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series.

o People aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series.

o People aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer[1]BioNTech primary series, based on their individual benefits and risks.

o People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer[1]BioNTech primary series, based on their individual benefits and risks.

Filed Under: City of GranadaCity of HollyCity of LamarCity of WileyCountyCOVID-19FeaturedHealthHot TopicsPublic Safety

Tags: CDPHECovid-19

Get the latest updates via email.

COVID-19 Update from PCPHE for October 6th, 2021 - The Prowers Journal

WHBL News 11 October, 2021 - 05:32pm

The Prowers County Test Positivity Rate as of October 6, 2021 is 4.9% out of a goal of 5%.  This is down from 9.22% post from last week.  There have been 33 cases in the county in the past seven days with one person having been vaccinated and 65 cases of COVID-19 in the past 14 days.  The cumulative number of cases is at 1,513 with 109 hospitalizations and 28 deaths, up one from the last report.  The 30-39 age bracket continues to post the highest number of cases at 225, followed by 20-29 and 60-69 age groups at just over 200 cases each.

This week Prowers County Department of Health and Environment are offering ALL 3 vaccine types Friday, 10/08/21 from 9:00-11:00AM and 2:00-4:00PM

o Only for those who received Pfizer vaccine as their primary series (for the first 2 doses).

o People 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series.

o People aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series.

o People aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer[1]BioNTech primary series, based on their individual benefits and risks.

o People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer[1]BioNTech primary series, based on their individual benefits and risks.

Filed Under: City of GranadaCity of HollyCity of LamarCity of WileyCountyCOVID-19FeaturedHealthHot TopicsPublic Safety

Tags: CDPHECovid-19

Get the latest updates via email.

Business Stories

JCPenney