Tag Archives: emergency use

Pfizer, BioNTech seek U.S. COVID-19 vaccine clearance for children 5-11

WASHINGTON (Reuters) -Pfizer Inc and BioNTech SE have asked U.S. regulators to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11, a group for whom no shot is currently allowed, Pfizer said on Thursday.

The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss the application, making it possible for children in this age group – numbering around 28 million – to begin receiving the two-dose Pfizer/BioNTech vaccine shortly afterward.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer wrote on Twitter.

The vaccine already has won U.S. emergency use authorization in teens ages 12 to 15 and is fully approved by regulators for people ages 16 and up.

The Pfizer/BioNTech vaccine is one of three in use in the United States, along with the two-dose Moderna vaccine and the single-dose Johnson & Johnson version, neither of which has won full regulatory approval for any age group.

A rapid authorization of the Pfizer/BioNTech vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors. If given regulatory authorization, the two-dose Pfizer/BioNTech vaccine would become the first COVID-19 shot made available to children 5 to 11 in the United States.

The Pfizer/BioNTech vaccine has been shown to induce a strong immune response in 5 to 11 year old’s in a 2,268-participant clinical trial, the companies said on Sept. 20.

The two drugmakers are also testing the vaccine in children ages 2 to 5 years old and children ages 6 months to 2 years, with data expected in the fourth quarter.

The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on CNN.

Once the authorization is granted, Zients said: “We are ready. We have the supply. We’re working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians’ offices and community sites.”

The United States leads the world in COVID-19 cases and deaths.

Children currently make up about 27% of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the coronavirus Delta variant among unvaccinated people.

While children are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.

A Pfizer spokesperson said the application to the FDA has been completed.

(Reporting by Susan Heavey in Washington and Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Will Dunham, Timothy Heritage and Saumyadeb Chakrabarty)

GSK and Vir seek emergency use of COVID-19 therapy in United States

(Reuters) -GSK and Vir Biotechnology have filed an application to U.S. regulators for emergency use authorization of their antibody therapy to treat early-stage COVID-19 infections, the drugmakers said on Friday.

Earlier this month, London-listed GSK and U.S.-based Vir found their experimental treatment, VIR-7831, reduced the risk of hospitalization and deaths among patients by 85%, based on interim data from a study.

The application is to treat adults and adolescents of over 12 yeas of age and weighing at least 40 kilograms that have mild-to-moderate COVID-19 and are at risk of being hospitalized due to severe illness which could also lead to death.

The United States has already recommended similar therapies from Eli Lilly and Regeneron, while European health regulators are reviewing treatments from the class of medicines called monoclonal antibodies.

These monoclonal antibodies are synthetically manufactured copies of the human body’s natural infection-fighting proteins and are already being used to treat some types of cancers. Regeneron’s therapy was given to former U.S. President Donald Trump during his COVID-19 infection.

GSK and Vir said they are in discussions with the European Medicines Agency and other global regulators for approvals of their treatment, part of a wider collaboration on developing COVID-19 drugs based on monoclonal antibodies.

(Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger in Frankfurt; Editing by Arun Koyyur and Krishna Chandra Eluri)

Pence gets COVID shot on TV as U.S. about to approve second vaccine

By Jeff Mason and Susan Heavey

WASHINGTON (Reuters) – U.S. Vice President Mike Pence received his COVID-19 vaccine live on television on Friday, seeking to shore up public support for vaccinations as U.S. regulators were on the cusp of approving a second vaccine for emergency use.

Pence said he “didn’t feel a thing” after he, his wife Karen Pence and Surgeon General Jerome Adams each rolled up their sleeves and took injections from white-coated medical staff, becoming the highest-profile recipients to receive the vaccine publicly.

After U.S. deaths from the coronavirus topped 3,000 for a third straight day, Pence called the vaccinations a sign of hope, with 20 million doses expected to be distributed nationwide before the end of December and hundreds of millions more going out in the first half of 2021.

“I also believe that history will record that this week was the beginning of the end of the coronavirus pandemic, but with cases rising across the country, hospitalizations rising across the country, we have a ways to go,” said Pence, leader of the White House coronavirus task force.

U.S. hospitalizations have set records on each of the past 20 days, approaching 114,000 on Thursday, according to a Reuters tally.

The United States reported a record 239,903 new cases on Thursday, when the U.S. death toll surpassed 311,000.

The situation was especially dire in California, with more than 50,000 new cases each of the past two days and many hospitals reporting their intensive care units are at or near capacity. That has triggered a renewal of sweeping stay-at-home orders across much of the state.

“We expect to have more dead bodies than we have spaces for them,” Los Angeles Mayor Eric Garcetti told a briefing on Thursday.

The Pences and Adams were injected with the vaccine developed by Pfizer Inc and German partner BioNTech SE, which was approved last week. A second vaccine, from Moderna Inc, was expected to win regulatory approval from the Food and Drug Administration on Friday, Pence said.

Those vaccines require two doses, given three or four weeks apart, while others under development may require only a single dose. All have been developed with unprecedented speed in less than a year, thanks to technological advances and the urgency of the global pandemic.

Beyond the logistical challenge of the most ambitious vaccination campaign in decades, health officials must convince a skeptical public they are safe and effective. A recent Reuters/Ipsos poll found only 61% of Americans were open to getting vaccinated.

Pence and Adams being vaccinated publicly “is symbolic to tell the rest of the country the time is now to step to the plate, and when your time comes, to get vaccinated,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease.

Frontline healthcare workers, first responders and nursing home residents have been given priority, but a parade of high-profile jabs could soon follow. Fauci, who still sees patients, has said he might receive the vaccine within days.

Former presidents Bill Clinton, George W. Bush and Barack Obama have volunteered for public inoculations, and Joe Biden will get his next week, his aides said.

President Donald Trump has encouraged people to get vaccinated and championed his administration’s Operation Warp Speed program to promote the development and distribution of vaccines.

(Reporting by Jeff Mason, Susan Heavey, Idrees Ali and Anurag |Maan; Writing by Daniel Trotta; Editing by Gareth Jones, Chizu Nomiyama and Dan Grebler)

Sinovac’s coronavirus vaccine candidate approved for emergency use in China- source

BEIJING (Reuters) – Sinovac Biotech Ltd’s coronavirus vaccine candidate CoronaVac was approved in July for emergency use as part of a program in China to vaccinate high-risk groups such as medical staff, a person familiar with the matter said.

China National Biotec Group (CNBG), a unit of state-owned pharmaceutical giant China National Pharmaceutical Group (Sinopharm), also said it had obtained emergency use approval for a coronavirus vaccine candidate in social media platform WeChat on Sunday.

CNBG, which has two vaccine candidates in phase 3 clinical trials, did not say which of its vaccines had been cleared for emergency use.

China has been giving experimental coronavirus vaccines to high-risk groups since July, and a health official told state media in an interview aired last week that authorities could consider modestly expanding the emergency use program to try to prevent possible outbreaks during the autumn and winter.

Officially, China has given little details on which vaccine candidates have been given to high-risk people under the emergency use program and how many people have been vaccinated.

State media reported in June, prior to the emergency use program, that employees at state firms travelling overseas were allowed to take one of the two vaccines being developed by CNBG, while China’s military had also approved the use of CanSino Biologics’ vaccine candidate.

Seven vaccines against the coronavirus are in final trial stages around the world, and four of them are from China.

But no vaccine has yet passed the final stage of trials proving it is safe and effective – conditions usually required to be met to get regulatory approval for mass use. COVID-19 has killed over 800,000 people worldwide.

(Reporting by Roxanne Liu in Beijing and Miyoung Kim in Singapore; Editing by Ana Nicolaci da Costa)