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Covaxin, Vaccine Developed in India, Gets W.H.O. Clearance

Covaxin, Vaccine Developed in India, Gets W.H.O. Clearance

Green Bay Packers star QB Aaron Rodgers will sit out Sunday’s road game against the Kansas City Chiefs due to Covid-19 protocols, according to his team.
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Head coach Matt LaFleur on Wednesday wouldn’t confirm if Rodgers tested positive for the virus or give his vaccination status. LaFleur told reporters that last season’s league MVP was in Covid-19 protocols.
Multiple outlets — including the NFL Network and ESPN — have reported that Rodgers tested positive for Covid-19, citing sources.
CNN has reached out to the Packers and the NFL for comment but has not yet gotten a response.
This is what Rodgers has said on the subject:
In August, when asked if he had received the Covid-19 vaccine, Rodgers said he had been “immunized.”
“There’s a lot of conversation around it, around the league and a lot of guys who have made statements and not made statements,” Rodgers said.
“Owners have made statements. There’s guys on the team that haven’t been vaccinated. I think it’s personal decision. I’m not going to judge those guys. There’s guys that have been vaccinated and contracted Covid. So it’s an interesting issue.”
Clubs are not permitted to comment on a player’s medical status other than referring to roster status, according to NFL and NFLPA policy.
Being placed on the reserve/Covid-19 list is for a player who tests positive or has been in close contact with an infected person.
Many medical facilities in Colorado are at 90 percent capacity, with intensive care units overflowing. Most of the people needing admission are unvaccinated. President Biden addressed the nation on pediatric doses of the Pfizer-BioNTech vaccine being made available for children 5 to 11.
The World Health Organization on Wednesday granted emergency authorization to Covaxin, the first coronavirus vaccine developed in India and to get the designation, providing a major boost for Prime Minister Narendra Modi, who has stressed his intention of making the country’s pandemic prevention effort self-reliant.

The vaccine was developed by Bharat Biotech, an Indian drug company, and the Indian Council of Medical Research, a government body, and is the eighth coronavirus vaccine to receive the global health body’s green light.

The W.H.O. said in a tweet that Covaxin met standards for protection against Covid-19 and that the benefit of the vaccine far outweighs the risks.

Mr. Modi’s government was already exporting the vaccine to gain favors in a geopolitical struggle with China, which has used its large infrastructure projects to bolster its image.

The W.H.O. said Covaxin had a 78 percent efficacy rate against Covid-19 and should be administered in two doses four weeks apart to adults, noting the vaccine’s easier storage requirements might be convenient for poor and developing countries.

On Wednesday, India’s top drug regulatory authority said that it was extending the shelf life of Covaxin from 6 to 12 months from the date of manufacture, based on data showing that it is safe and effective.

Mr. Modi, who got his first shot of the vaccine in March, said at the Group of 20 summit in Rome last week that his country will be able to produce over five billion vaccine doses overall next year to help the world in the fight against the pandemic.

Covaxin was approved by Indian government officials in January and administered to millions of people even without data being released. Many in the country, including frontline health care workers, had feared that Covaxin could be ineffective or worse, slowing down the national campaign to inoculate 1.3 billion people.

Officials in Brazil, where the government had bought doses of Covaxin, had raised questions about the vaccine and were investigating possible irregularities in its contract to buy 20 million shots of Covaxin from India.

Covaxin is being manufactured in three different locations in India, with the current production at over 50 million doses per month. The company has said it is aiming to make 1 billion doses per year by the end of this year.

The W.H.O.’s sign-off comes after a lengthy review period; the manufacturers applied in April and provided the first batch of data to the agency on July 6, addressing a host of issues, including the vaccine safety and efficacy.

Covaxin’s manufacturers said in a statement on Wednesday that the W.H.O.’s validation would help expedite requests from countries seeking to buy the vaccine.

Dr. Krishna Ella, a top official at Bharat Biotech, said that the organization has focused on maintaining stringent quality and safety standards.

The authorization “will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally,” he said.

Worldwide, about 75 percent of all Covid shots have been administered in high- and upper-middle-income countries, according to the Our World in Data project at the University of Oxford. Only 0.6 percent of doses have been administered in low-income countries.
The conference — COP26, organized by the United Nations — brought together world leaders and other delegates to set goals for cutting greenhouse gas emissions. Mr. Garcetti was attending as the chair of C40, a group of mayors from around the world who want to deliver action on climate change.

The conference required participants from outside Britain to take both a rapid coronavirus test and a more sensitive PCR test upon arrival in the country. Each day of the conference, participants also had to self-administer a rapid test and register a negative result online in order to be able to enter the event’s main venues.

Harrison Wollman, the mayor’s press secretary, wrote in an email that Mr. Garcetti “was taking regular rapid antigen tests daily while at the conference, and those all came back negative. He took a PCR test in preparation for his flight home, and that result was positive.”

Mr. Garcetti spoke on Monday at the World Leaders Summit and on Tuesday at a C40 event. He skipped some events on Wednesday and isolated himself in his hotel room after he tested positive.

As for how long the mayor would remain there, Mr. Wollman said, “We are still determining next steps, but the mayor will follow the advice of British public health experts.”

Frustrations among attendees over long security lines at the conference have been mounting — some complained that they had to wait in line for more than an hour. Verification of negative tests and capacity limits for meeting rooms were contributing to the logistical problems.

Masks were required at the conference, but attendees could be seen with their masks lowered rather than covering their mouths and noses, and there was no social distancing. The crowded conditions fueled concerns that poor air circulation in the conference venues could create an environment conducive to spreading the virus.

Organizers of the conference released a letter on Tuesday apologizing for the difficulties.
Almost 97 percent of active-duty members of the Air Force — the first branch of the U.S. military to reach its deadline for coronavirus vaccinations — have received at least one dose of vaccine, military officials said Wednesday. That percentage is in line with those for active-duty military members in most branches of service whose deadlines have not yet arrived.

Though the 10,636 Air Force members who remain unvaccinated are only a small sliver of the branch’s 326,855 active-duty troops, they still represent a large number of people to be facing possible expulsion for failing to comply with the vaccine mandate the Pentagon issued in August.

Many of them have requests pending for an exemption of some kind.

Some 4,933 troops have sought a religious exemption, but so far, not a single member of the military has been granted one. A smaller number have been given an administrative exemption — for example, because they are planning to leave the military soon — and others have received medical exemptions, some of which could be reversed if their medical condition changed. The Air Force said it would take 30 days to review all pending exemption requests.

For the military as a whole, about 97 percent of active-duty forces have had at least one dose of vaccine, and nearly 88 percent are fully vaccinated. The Navy leads the charge, with nearly 99 percent having at least one dose. When the National Guard and Reserves are included as well, though, they drag down the figures considerably, with only 69 percent of all forces fully vaccinated. In the Marines, for example, 86 percent of active-duty troops are fully vaccinated, but only 52 percent of Reserve troops are.

The vaccination deadline for the Navy and Marines arrives later this month. The Army, the largest service branch, has set a date in mid-December. Members of the Guard and Reserves in all branches will also be given more time. Civilian Pentagon employees are required to be fully vaccinated by Nov. 22.

Refusing the vaccine without an exemption is grounds for expulsion from the military, but Defense Secretary Lloyd J. Austin III has given commanders wide latitude to decide how to coax, cajole and ultimately punish those who won’t get shots.

“Each case is going to be treated specifically and individually, as it ought to be,” John Kirby, a spokesman for Mr. Austin, said this week. “Can we promise you that there will be absolute uniformity across the board? No.”

Vaccine reluctance in the military and the Department of Veterans Affairs mirrors that in civilian society, where vaccination rates are generally lower among people who do not face a strict vaccine mandate.
In Houston, Texas Children’s Hospital on Wednesday morning tackled the first of some 35,000 pediatric Covid-19 vaccine appointments, a rush that officials said had been booked in just five days. Nationally, Walgreens and CVS pharmacies opened appointment lines for millions of miniature doses. And amid a deluge of demand from parents desperate to get their children at least partially inoculated by Thanksgiving, Dr. Eric Ball realized he would have to skip some of his friend’s daughter’s bat mitzvah.

“Yeah,” the Orange County, Calif., pediatrician said, laughing. “Looks like I’ll be vaccinating kids in my suit this Saturday.”

With the blessing of federal authorities — and just in time for yet another stressful holiday season — health care providers mobilized nationally this week for a fresh wave of inoculations, this time featuring smaller shots in smaller arms.

Late Tuesday, the Centers for Disease Control and Prevention recommended the Pfizer-BioNTech coronavirus vaccine for children aged 5 through 11. The decision was in line with the Food and Drug Administration, which on Friday authorized emergency use of the pediatric dose for the roughly 28 million children in that age group.

Polls indicate that roughly a third of U.S. parents plan to leave their elementary-school-age children unvaccinated. But the latest vaccine announcement came as a relief not only to millions of families exhausted by the pandemic, but to public health officials who said it might help prevent a repeat of the terrifying surge of disease that swept the country last winter.

Although the infection rate in the United States plummeted for weeks as the reach of the contagious Delta variant ebbed, federal officials have warned that another spike is still possible. Absent vaccination, they say, younger children are vulnerable to hospitalization and, in the most rare cases, death from Covid-19, and they can transmit the virus to people of all age groups.

The Biden administration has enlisted 20,000 pediatricians, family doctors and pharmacies to administer the shots and is shipping 15 million doses. About five million of them are allocated to pharmacies in the federal program that have been key to the adult vaccination rollout. The other 10 million are allocated to states.
HOUSTON — Surrounded by anxious and excited parents, the first young children in Texas — and some of the first in the nation — were vaccinated against the coronavirus early on Wednesday.

The first two doses at Texas Children’s Hospital went to Paxton Bowers, 5, a leukemia patient at the hospital, and his brother Patrick, 9, before the sun had risen.

See Also
When the COVID vaccine is coming for kids under 12 : Shots

More than 35,000 children 5 to 11 have been signed up for shots at Texas Children’s so far, and hundreds of them were expected to be immunized on Wednesday.

The Centers for Disease Control and Prevention endorsed pediatric doses of the Pfizer-BioNTech coronavirus vaccine for children in that age group on Tuesday, a move that expands eligibility for the vaccine to 29 million younger Americans and will ease the worries of many pandemic-weary parents.

The younger children get one-third of the vaccine dosage that has been cleared for adults and children 12 or older, delivered using smaller needles and different vials to minimize the chance of confusion with adult doses.

About 2.9 million children aged 5 to 11 live in Texas. Twenty-two children in that age group have died from complications of Covid-19 in the state, and 118 have been diagnosed with Multisystem Inflammatory Syndrome in Children following a coronavirus infection, according to the Texas Department of State Health Services.

At the hospital in Houston, the surroundings resembled vaccination sites nationwide, with some modifications for a younger crowd. Several support dogs roamed among the nurses. “The Little Mermaid” played on a large screen in the post-injection monitoring area, which was decorated with Disney-character balloons. Chairs were set up in pairs so that children could sit with a parent or caregiver.

In the vaccination rooms, cheers mixed with yelps and a little bit of crying. Some children squirmed. Others jumped for joy.

“This is the best day ever!” said Elizabeth Burke, a sixth grader who celebrated her 12th birthday on Wednesday by getting her shot. She was the youngest of three children in her family, and the last to get immunized.

“We’ve kept her pretty isolated; we followed all the rules,” said her mother, Lauren Burke. “She was really a trooper.”

Nearby, Camryn Zoë Emanuel, 8, a third grader, said she looked forward to being able to spend more time with friends. “Just have more hang-outs,” she said. As for the shot, “it didn’t hurt that much,” she said, “but it kind of hurt.”

“She was real brave,” said her mother, Sonja Emanuel, who brought her daughter in from the Houston suburb of Missouri City. “This is something she wanted.”

The hospital was also giving shots to parents who wanted a first dose or a booster. Ms. Emanuel sat for a booster after her daughter got her shot.

“It’s a relief,” said Scott Solomon, who watched as his three children, 11, 9, and 6, all got vaccinated on Wednesday. “We went in birth order,” he said.

Thomas, his youngest, squirmed as the nurse prepared the shot. His mother, Catharina Solomon, held him on her lap. “We’re doing this to protect you, bud,” she said. “Thomas, look at the doggy!”

Next to him sat a golden retriever comfort dog, his paws raised by the handler to give Thomas a pair of high-fives.

Thomas cried. His brother Nicholas, 9, tried to talk him through it. Then the shot was over.

“Dad, I get to punch you now!” Thomas said, standing up and walking over to Mr. Solomon.

Then he showed the neon Band-Aid on his leg where the shot had gone in. He said it hurt a little, and now he was ready for a treat.

“I’m going to get a doughnut,” he said.

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