Fogbow

Regulators on Friday authorized the Pfizer-BioNTech coronavirus vaccine for children 5 to 11 years old, a watershed moment celebrated by parents yearning for a return to normal life but viewed with ambivalence and outright skepticism by others worried about the potential risk of unknown side effects.

The Food and Drug Administration’s emergency clearance is for a two-shot regimen administered three weeks apart. The dose, 10 micrograms, is one-third that used for adolescents and adults. In a clinical trial of 5- to 11-year-olds, the vaccine was almost 91 percent effective at preventing covid-19, the illness caused by the virus. The vaccine’s safety was studied in about 3,100 children who received the shot and had no serious side effects, the agency said.

pipistrelle wrote: ↑Fri Oct 29, 2021 10:48 am A different but competent spokesperson is going to say the same things and the same minds are going to be just as closed to truth and open to conspiracy.

"(CNN)The Supreme Court on Friday denied a request to block a Maine rule that requires certain health care employees to be fully vaccinated against Covid-19.

A group of unvaccinated workers argued that the vaccine mandate violated their religious liberty rights.
The court's right wing -- Justice Neil Gorsuch, Clarence Thomas and Samuel Alito -- dissented and would have halted the mandate.
The court's move is the latest instance in which the justices have turned away a request to halt a vaccine mandate and it comes as states are grappling with the delta variant.
This story is breaking and will be updated.
"

CDC finds immunity from vaccines is more consistent than from infection, but both last at least six months
Naturally acquired immunity is at the center of a political fight over President Biden’s vaccine mandates.

By Lena H. Sun and Joel Achenbach
November 1, 2021 at 5:04 p.m. EDT

It’s a question that scientists have been trying to answer since the start of the pandemic, one that is central to the rancorous political debates over coronavirus vaccine policies: How much immunity does someone have after recovering from a coronavirus infection, and how does it compare with immunity provided by vaccination?

The Centers for Disease Control and Prevention has weighed in for the first time in a detailed science report released with little fanfare Friday evening. Reviewing scores of research studies and its own unpublished data, the agency found that both infection-induced and vaccine-induced immunity are durable for at least six months — but that vaccines are more consistent in their protection and offer a huge boost in antibodies for people previously infected.

In comparing the two types of immunity, scientists said research shows vaccination provides a “higher, more robust, and more consistent level of immunity to protect people from COVID-19 than infection alone.”

Coronavirus infections can cause severe disease or no symptoms at all, and the CDC found that antibody levels vary widely from one individual to another after an infection. The report also notes that there is no test authorized by the Food and Drug Administration that would enable doctors and the public to reliably measure an individual’s protection from disease. And although higher levels of neutralizing antibodies generally signal higher protection, scientists don’t know precisely what level of antibodies will protect an individual.



https://www.washingtonpost.com/health/2 ... -immunity/

Federal Government Cuts Ties With Troubled Vaccine Maker
Emergent BioSolutions ruined millions of doses of Covid-19 vaccines. Now its $600 million deal is canceled.

By Chris Hamby
Nov. 4, 2021

WASHINGTON — The federal government has canceled its contract with a troubled Covid-19 vaccine manufacturer that ruined millions of doses and had to halt production for months after regulators raised serious quality concerns.

The decision marks a stark reversal of fortune for the politically connected contractor, Maryland-based Emergent BioSolutions, and an abandonment by the government of a deal that was supposed to be a centerpiece of Operation Warp Speed.

Early in the pandemic, the government decided to bank on the company to be the sole domestic manufacturer of the Johnson & Johnson and AstraZeneca vaccines. But this March, testing found that a batch of the Johnson & Johnson vaccine had been contaminated, and Emergent agreed to pause manufacturing after an inspection uncovered a host of problems at its facility in Baltimore’s Bayview area.

The termination of the contract, disclosed on Thursday by Emergent executives during a call with investors, was the result of negotiations that began after the government earlier this year stopped making payments under the deal, which was awarded in May 2020 and was worth more than $600 million. Emergent will now forgo roughly $180 million of that amount, according to company disclosures.



https://www.nytimes.com/2021/11/04/us/e ... ccine.html

Moderna and U.S. at Odds Over Vaccine Patent Rights
Moderna’s patent application names several employees as the sole inventors of a crucial component of its coronavirus vaccine, excluding three government scientists.


By Sheryl Gay Stolberg and Rebecca Robbins
Nov. 9, 2021

WASHINGTON — Moderna and the National Institutes of Health are in a bitter dispute over who deserves credit for inventing the central component of the company’s powerful coronavirus vaccine, a conflict that has broad implications for the vaccine’s long-term distribution and billions of dollars in future profits.

The vaccine grew out of a four-year collaboration between Moderna and the N.I.H., the government’s biomedical research agency — a partnership that was widely hailed when the shot was found to be highly effective. A year ago this month, the government called it the “N.I.H.-Moderna Covid-19 vaccine.”

The agency says three scientists at its Vaccine Research Center — Dr. John R. Mascola, the center’s director; Dr. Barney S. Graham, who recently retired; and Dr. Kizzmekia S. Corbett, who is now at Harvard — worked with Moderna scientists to design the genetic sequence that prompts the vaccine to produce an immune response, and should be named on the “principal patent application.”

Moderna disagrees. In a July filing with the United States Patent and Trademark Office, the company said it had “reached the good-faith determination that these individuals did not co-invent” the component in question. Its application for the patent, which has not yet been issued, names several of its own employees as the sole inventors.

The N.I.H. had been in talks with Moderna for more than a year to try to resolve the dispute; the company’s July filing caught the agency by surprise, according to a government official familiar with the matter. It is unclear when the patent office will act, but its role is simply to determine whether a patent is warranted. If the two sides do not come to terms by the time a patent is issued, the government will have to decide whether to go to court — a battle that could be costly and messy.



https://www.nytimes.com/2021/11/09/us/m ... atent.html

WASHINGTON (AP) — About 900,000 kids aged 5-11 will have received their first dose of the COVID-19 vaccine in their first week of eligibility, the White House said Wednesday, providing the first glimpse at the pace of the school-aged vaccination campaign.

Final clearance for the shots was granted by federal regulators on Nov. 2, with the first doses to kids beginning in some locations the following day. Now nearly 20,000 pharmacies, clinics and physicians’ offices are administering the doses and the Biden administration estimates that by the end of Wednesday more than 900,000 of the kid doses will have been administered. Additionally about 700,000 first-shot appointments are also scheduled for the coming days.

About 28 million 5-11 year-olds are now eligible for the Pfizer vaccine at a dose that’s a third of the amount given to teens and adults.

Kids who begin the two-dose regimen by the end of next week will have full protection from the vaccines by Christmas.

Unvaccinated Texans 40 times as likely to die of covid as those fully vaccinated in 2021, study says

By Paulina Firozi
Yesterday at 1:23 p.m. EST

A vast majority of Texans who have died of covid-19 since the beginning of the year were unvaccinated, according to a grim new Texas health department report released Monday.

The report from the Texas Department of State Health Services examined data from Jan. 15 to Oct. 1 and found that unvaccinated people were much more likely to get infected and die of the coronavirus than those who got their shots.

Of the nearly 29,000 covid-linked fatalities in Texas during that period, more than 85 percent were of unvaccinated individuals. Nearly 7 percent of the deaths were among partially vaccinated people, while nearly 8 percent were fully vaccinated.

The figures highlight just how much more at risk the unvaccinated population has been this year: In all age groups, the state’s unvaccinated were 40 times more likely to die than fully vaccinated people. The study also found that the unvaccinated in all age groups were 45 times more likely to have a coronavirus infection than fully vaccinated people. It also looked closely at data from September and underlined the impact of the highly contagious delta variant, which fueled a surge in Texas, as it did in much of the country.



https://www.washingtonpost.com/health/2 ... her-covid/

raison de arizona wrote: ↑Wed Nov 10, 2021 7:07 pm Now he's trying to grok why he has to wait for the next dose.

AstraZeneca to start taking ‘modest’ profits from Covid-19 vaccine
Alex Ralph
Friday November 12 2021, 10.00am GMT, The Times

AstraZeneca is to begin generating “modest” profits from its Covid-19 vaccine for new orders, having previously committed itself to operating at cost during the pandemic stage of the crisis.

The Anglo-Swedish pharmaceuticals group said that it was “now expecting to progressively transition the vaccine to modest profitability as new orders are received”.

Revealing the plans alongside its third-quarter results, it said that Covid-19 vaccine sales in the fourth quarter were expected to be a “blend of the original pandemic agreements and new orders, with the large majority coming from pandemic agreements”.

There has been uncertainty over AstraZeneca’s longer-term commercial plans for Vaxzevria, the name of the vaccine. Earlier this week the company created a dedicated unit for its vaccines and antibody therapies to combine research





paywall https://www.thetimes.co.uk/article/astr ... -6jl8g5v3d

DURBAN, South Africa — Pfizer announced a deal on Tuesday to allow its promising Covid-19 treatment to be made and sold inexpensively in 95 poorer nations that are home to more than half of the world’s population. The agreement follows a similar arrangement negotiated by Merck last month, and together the deals have the potential to vastly expand global production of two simple antiviral pills that could alter the course of the pandemic by preventing severe illness from the coronavirus.

“The fact that we now have two manufacturer-anywhere licenses for these two drugs is a big change, and it draws a big contrast with the restrictive licensing so far for vaccines,” said James Love, who leads Knowledge Ecology International, a nonprofit that researches access to medical products. Under the agreement, Pfizer will grant a royalty-free license for the pill to the Medicines Patent Pool, a nonprofit backed by the United Nations, in a deal that will allow manufacturers to take out a sublicense. They will receive Pfizer’s formula for the drug, and be able to sell it for use in 95 developing countries, mostly in Africa and Asia, once regulators authorize the drug in those places.

The organization reached a similar deal with Merck for its Covid antiviral pill, molnupiravir, to be made and sold inexpensively in 105 poorer countries. Nevertheless, there are serious concerns about whether this step will do enough to ensure sufficient supply of the drug for countries that continue to lack Covid vaccines. Like the Merck deal, the Pfizer agreement excludes a number of poorer countries that have been hit hard by the virus. Brazil, which has one of the world’s worst pandemic death tolls, as well as Cuba, Iraq, Libya and Jamaica, will have to buy pills directly from Pfizer, most likely at higher prices compared with what the generics manufacturers will charge, and those countries risk getting shut out of supplies.

RTH10260 wrote: ↑Thu Nov 18, 2021 11:23 am Likely correct, and those countries that will get production services thru licenses manage by UN l WHO would anyhow not be marketing targets anytime soon if ever by big pharma. Also prevents that countries (think India) shanghai the patents thru imminent domain procedures and the ensuing legal hassles.

WASHINGTON (AP) — U.S. regulators on Friday moved to open up COVID-19 booster shots to all adults, expanding the government’s campaign to shore up protection and get ahead of rising coronavirus cases that may worsen with the holidays.

Pfizer and Moderna announced the Food and Drug Administration’s decision after at least 10 states already had started offering boosters to all adults. The latest action stands to simplify what until now has been a confusing list of who’s eligible by allowing anyone 18 or older to choose either company’s booster six months after their last dose — regardless of which vaccine they had first.

But there’s one more step: The Centers for Disease Control and Prevention must agree to expand Pfizer and Moderna boosters to even healthy young adults. Its scientific advisers were set to debate later Friday.

If the CDC agrees, tens of millions more Americans could have three doses of protection ahead of the new year. Anyone who got the one-dose Johnson & Johnson vaccine can already get a booster.