Tag Archives: Pfizer-BioNTech

Over 900,000 U.S. kids to get first COVID-19 shot by end of Wed -White House

WASHINGTON (Reuters) -Over 900,000 U.S. children aged 5-11 are expected to have received their first COVID-19 vaccine shot by the end of Wednesday, White House COVID-19 coordinator Jeff Zients said, as the government ramped up vaccinations of younger children.

The United States on Wednesday began administering Pfizer/BioNTech’s COVID-19 vaccine to children ages 5 to 11, the latest group to become eligible for the shots that provide protection against the illness to recipients and those around them.

“While our program is just fully up and running this week, by the end of the day today, we estimate that over 900,000 kids aged five through 11 will have already gotten their first shot,” Zients said during a briefing with reporters.

The figure comes from a White House analysis of available data from pharmaceutical partners, some states, and localities, Zients said, adding the CDC has not yet collected the full tally.

COVID-19 is the largest vaccine-preventable killer of children in that age group, with 66 children dying from it over the past year, U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said at the same briefing.

The seven-day average of total COVID-19 cases in the U.S. was flat at about 73,300 over the past week, she said, with the hospitalization rate also flat at 5,000 a day. The seven-day average of daily deaths fell 11% to around 1,000 per day.

(Reporting by Susan Heavey, Alexandra Alper, and Ahmed Aboulenein; Editing by Nick Zieminski and David Gregorio)

U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

By Manas Mishra and Michael Erman

(Reuters) -An expert panel will weigh authorization of Pfizer Inc and BioNTech’s COVID-19 vaccine for U.S. children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the federal Food and Drug Administration.

An authorization is an important regulatory step toward reaching about 28 million children of these ages, most of them back in school for in-person learning.

The FDA need not follow the advice of its outside experts, but usually does.

While children rarely become seriously ill or die from COVID-19, some develop complications, and COVID-19 cases in unvaccinated children have risen due to the contagious Delta variant.

The age group is “far from being spared from the harm of COVID-19,” with the virus now one of the top 10 causes of deaths in American children, FDA official Peter Marks told the panel. He said there had been close to 100 deaths in that age group so far, and 1.9 million infections.

“In addition, infections have caused many school closures and disrupted the education and socialization of children,” he said.

FDA staff, in documents posted before the meeting, said the likely vaccine benefits in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.

Only a few other countries, including China, Cuba and the United Arab Emirates, have cleared COVID-19 vaccines for children in this age group and younger.

Since May, the World Health Organization has been urging rich countries to reconsider plans to vaccinate children and instead donate COVID-19 shots to the COVAX scheme for poorer countries.

The advisers are expected to pay close attention to the rate of the rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.

Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for ages 12-15 since May and cleared for everyone over 16 since December.

The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

After the FDA, a panel to the U.S. Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.

Top U.S. infectious disease expert Anthony Fauci said on Sunday that it was likely the vaccine will be available to children in the first week or two of November.

If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said.

“No matter what size of the safety database, there will always be uncertainties regarding benefits and risks, including for example, the risk of vaccine-associated myocarditis,” said Doran Fink, the FDA’s deputy director for vaccine development.

These uncertainties have to be addressed in surveillance data and studies following authorization, Fink told the panel.

Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Caroline Humer, Richard Chang and Jonathan Oatis)

Factbox: Countries respond to heart inflammation risk from mRNA shots

(Reuters) – Some countries have halted altogether or are giving only one dose of COVID shots based on so-called mRNA technology to teens following reports of possible rare cardiovascular side effects.

Europe’s drug regulator said in July it had found a possible link between a very rare inflammatory heart condition and COVID-19 vaccines from Pfizer/BioNTech and Moderna.

However, the benefits of mRNA shots in preventing COVID-19 continue to outweigh the risks, European and U.S. regulators and the World Health Organization have said.

Here are some of the steps some countries are taking:

CANADA

The Public Health Agency of Canada said data suggested that reported cases of rare heart inflammation were higher after Moderna’s COVID-19 vaccine compared with the Pfizer/BioNTech shots.

SWEDEN

Sweden paused the use of Moderna’s COVID-19 vaccine for younger groups, citing data from a yet unpublished Nordic study.

The Swedish health agency said it would pause using the shot for people born in 1991 and later as data pointed to an increase of myocarditis and pericarditis among youths and young adults that had been vaccinated.

DENMARK

The Danish Health Agency said on Friday that it was continuing to offer Moderna’s COVID-19 vaccine to under-18s, and that a statement on Wednesday suggesting a suspension had in fact been a miscommunication.

FINLAND

Finland paused the use of Moderna’s vaccines for younger people and instead would give Pfizer’s vaccine to men born in 1991 and later. It offers shots to those aged 12 and over.

HONG KONG

A panel of health experts advising the Hong Kong government has recommended in September children aged 12-17 should get only one dose of BioNTech’s COVID-19 vaccine after reports of heart inflammation as a side effect.

NORWAY

Norway is giving one dose of Pfizer/BioNTech vaccine to children aged 12-15.

UNITED KINGDOM

Britain has been offering all 12-15-year-olds a first a shot of the Pfizer/BioNTech vaccine. Second doses would not be offered to the age group until at least spring when there may be more data from around the world.

(Compiled by Antonis Triantafyllou; Editing by Anna Pruchnicka and Tomasz Janowski)

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)

U.S. FDA advisers may vote on COVID-19 boosters for older adults after rejecting broad approval

By Manojna Maddipatla and Michael Erman

(Reuters) – A panel of expert outside advisers to the U.S. Food and Drug Administration voted against broadly approving COVID-19 vaccine booster shots, but may vote on a narrower approval for older adults later on Friday.

The panel voted overwhelmingly against approving boosters for Americans age 16 and older, potentially undermining the Biden administration’s plan to roll out third shots of the Pfizer/BioNTech vaccine as soon as next week.

But there was widespread support among panelists for a third dose for older Americans, who are at higher risk of severe COVID-19 and may be more likely to have waning immunity after the first rounds of shots. FDA officials said that a vote to recommend approval for such groups was possible later on Friday.

The FDA will take the panel’s recommendation into consideration in making its decision on the boosters. But it can reject the advice as it did recently in approving Biogen Inc’s controversial Alzheimer’s drug

Many committee members were critical of the booster plan, arguing that the data presented by Pfizer and the FDA was incomplete and that the request for approval for people as young 16 is too broad. Most of them said they were not needed yet for younger adults.

Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency’s top scientists arguing they are not needed yet.

If the FDA goes ahead and approves the booster, a separate panel advising the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.

The White House said it was ready to roll out boosters next week if health officials approve the plan.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Mike Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)

United States buys 200 million more doses of Pfizer/BioNTech COVID-19 vaccine

(Reuters) -Pfizer Inc and German partner BioNTech said on Friday the U.S. government has purchased 200 million additional doses of their COVID-19 vaccine to help with pediatric vaccination as well as possible booster shots – if they are needed.

A Biden administration official with knowledge of the contract said that as part of the agreement, Pfizer will provide the United States with 65 million doses intended for children under 12, including doses available immediately after the vaccine is authorized for that age group.

The U.S. government also has the option to buy an updated version of the vaccine targeting new variants of the virus.

The deal comes as the Delta variant of the coronavirus sweeps across the country and drives up infections, contributing to the debate over whether or not Americans will need a booster dose this fall.

It also follows the government’s move in June to buy 200 million more doses of Moderna Inc’s COVID-19 vaccine.

The purchase brings the total number of doses of the Pfizer/BioNTech vaccine to be supplied to the United States to 500 million, of which roughly 208 million doses have already been delivered, as of Thursday’s data from the government.

“These additional doses will help the U.S. government ensure broad vaccine access into next year,” Pfizer Chief Executive Officer Albert Bourla said in a statement.

Pfizer last year signed a deal with the U.S. government for 100 million doses of the vaccine for nearly $2 billion, with an option to buy 500 million more doses.

A majority of the new doses will be supplied by the end of the year, and the remaining 90 million will be delivered by April 30, the companies said.

Pfizer and BioNTech have designed a new version of their vaccine targeting the Delta variant, which they plan to test in the coming weeks, but have said the current vaccine could also provide protection against the variant.

Pfizer earlier this month said the companies plan to seek authorization from U.S. and European regulators for a booster dose of their COVID-19 vaccine.

The U.S. government has said Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time.

Advisers to the U.S. Centers for Disease Control and Prevention on Thursday considered evidence suggesting that a booster dose of COVID-19 vaccines could increase protection among people with compromised immune systems.

CDC scientists told advisers that boosters for the immunocompromised would need to wait for regulatory action from the U.S. Food and Drug Administration – either full approval of vaccines or amendments to their current emergency use authorizations – before the CDC could make a recommendation.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Sriraj Kalluvila, Maju Samuel and Dan Grebler)

Third-trimester vaccination appears safe; Pfizer/BioNtech vaccine effective in those with chronic illnesses

By Nancy Lapid

(Reuters) -The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Third-trimester vaccination appears safe in early data

Among pregnant women who received COVID-19 vaccines manufactured by Pfizer Inc and BioNTech SE or Moderna Inc and who signed up for an online survey, side effects were no different than what has been seen in the general population, researchers reported Wednesday in The New England Journal of Medicine. But they noted that data of this nature is still sparse. They looked at responses from smartphone users who participated in the U.S. Centers for Disease Control and Prevention (CDC) “v-safe” program, which collects information on COVID-19 vaccination experiences. Compared to non-pregnant women, the 35,691 pregnant responders reported more injection site pain but fewer headaches, muscle aches, chills, and fevers. Among 3,958 women who signed up for a CDC pregnancy registry, no one vaccinated in the first trimester has given birth yet. The Vaccine Adverse Event Reporting System (VAERS), run jointly by the CDC and the U.S. Food and Drug Administration, has recorded 46 miscarriages potentially related to COVID-19 vaccination, including 37 in the first trimester, the researchers said. “Early data from the v-safe surveillance system, the v-safe pregnancy registry, and the VAERS do not indicate any obvious safety signals with respect to pregnancy or neonatal outcomes associated with Covid-19 vaccination in the third trimester of pregnancy,” researchers concluded.

Pfizer/BioNTech vaccine effective in people with chronic illnesses

The Pfizer/BioNTech COVID-19 vaccine is effective at preventing symptomatic and severe disease in people with some chronic illnesses, like diabetes and heart disease, according to a large real-world study published on Wednesday in The New England Journal of Medicine. The analysis of almost 1.4 million people, conducted by Clalit, Israel’s largest healthcare provider, showed the vaccine was 80% effective against symptomatic infection for people with heart or chronic kidney diseases, 86% for people with type 2 diabetes, 75% for cerebrovascular disease, and 84% for people suffering from immunodeficiency. For vaccinated people with at least three chronic conditions or risk factors, the vaccine was 88% effective in preventing symptomatic infection. It was more than 90% effective against severe disease for people with type 2 diabetes, heart or cerebrovascular disease. The results were lower than the 95% overall vaccine effectiveness observed after the second dose in clinical trials last year. “These results are very encouraging, as they suggest that most COVID-19 cases will be prevented by vaccination even in the elderly and chronically ill,” said Ran Balicer, Clalit’s chief innovation officer.

Fever, shortness of breath are COVID-19 red flags in pregnancy

Pregnant women with COVID-19 and their newborns face “consistent and substantial increases” in risks of complications, an international study has found. COVID-19 in newborns is associated with a three-fold risk of severe medical complications, according to the study by scientists at the University of Oxford. And pregnant women with symptomatic COVID-19 face higher risks of preterm delivery, preeclampsia (high blood pressure with organ failure risk), need for intensive care and death. That was particularly true for women with fever and shortness of breath, according to a report published on Friday in JAMA Pediatrics. “Women with COVID-19 during pregnancy were over 50% more likely to experience pregnancy complications compared to pregnant women unaffected by COVID-19,” said co-author Aris Papageorghiou. The study, conducted in 18 countries, included 706 pregnant women with COVID-19 and 1,424 similarly pregnant women without COVID-19 who were giving birth at the same hospital. Findings also showed a delivery by Caesarean section may be associated with an increased risk of virus infection in newborns. Breastfeeding, however, does not seem to heighten risks of transmission from mothers to babies, they found.

(Reporting by Nancy Lapid and Maayan Lubell; Editing by Bill Berkrot)

U.S. pauses J&J COVID-19 vaccine over rare blood clots

By Manas Mishra and Michael Erman

(Reuters) – U.S. federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine after six women under 50 developed rare blood clots after receiving the shot, dealing a fresh setback to efforts to tackle the pandemic.

The move comes a week after European regulators said they had found a possible link between AstraZeneca’s COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.

Johnson & Johnson’s (J&J) single dose vaccine – most COVID-19 shots are delivered over two doses – and AstraZeneca’s low-cost vaccine are seen as vital tools in the fight against a pandemic that has claimed more than three million lives.

Most of the available J&J vaccine has been used in the United States due to production issues that have limited the company’s supply. As of April 12, more than 6.8 million doses of the J&J vaccine had been administered in the United States, compared with more than 180 million shots combined of the Moderna and Pfizer/BioNTech shots.

An advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Wednesday to review the cases, and the U.S. Food and Drug Administration (FDA) will review the analysis, the agencies said in a joint statement.

All six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination.

In the cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

The CDC and FDA said the adverse events appeared to be extremely rare.

“I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about,” Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.

“People are asking me if they should cancel their J&J vaccine appointments and I have told them not to but I know many will and this will stall progress in controlling the pandemic.”

J&J said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the COVID-19 vaccine made by its Janssen unit.

One woman died and a second in Nebraska has been hospitalized in a critical condition, the New York Times reported, citing officials.

‘ABUNDANCE OF CAUTION’

“The FDA recommendation to pause the administration of the Johnson and Johnson vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side effect not seen with the other vaccines,” said Dr. Robert Klugman at the UMass Memorial Medical Center in Massachusetts in an email.

“While the incidence is very low, the severity and potential for brain damage and other blood clot-related injuries is of great concern.”

J&J’s shares were down 3% before the opening bell.

The U.S. move comes less than a week after Europe’s drugs regulator said it was reviewing rare blood clots in four people in the United States who had received the J&J shot.

The J&J and AstraZeneca vaccines both use an adenovirus vector – a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the COVID-19-causing virus.

Among leading global COVID-19 vaccine developers, China’s CanSino Biological and Russia’s Gamaleya Institute with its Sputnik V vaccine are also relying on this approach. The Pfizer/BioNtech and Moderna vaccines use mRNA technology.

The rollout of J&J’s vaccine has been slowed by issues at production plants.

The company has supplied the United States with at least 20 million doses but is behind schedule on its deliveries. Problems at a Baltimore, Maryland plant run by outside contractor Emergent BioSolutions forced the companies to trash a batch of vaccine substance.

The plant – meant to be one of J&J’s main U.S. manufacturing facilities – has yet to be approved by U.S. regulators to supply vaccine doses, and J&J shipments to the states were expected to fall sharply next week.

J&J only began delivering its COVID-19 vaccine to European Union countries this week. It has committed to delivering 55 million doses to the bloc by the end of June and another 120 million in the third quarter.

J&J has been doing vaccinations in South Africa to study the effects on health workers, and had vaccinated just under 300,000 people there as of Monday, according to data from the country’s health department. J&J recently struck a deal with the African Union for up to 400 million doses.

Europe’s drugs regulator continues to recommend the use of AstraZeneca’s COVID-19 vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.

Australia has no current plans to add J&J’s coronavirus vaccine to its immunization drive, authorities said on Tuesday, as it moves away from procuring vaccines under review for potential links to blood clots.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in Maplewood, N.J., additional reporting by Julie Steenhuysen in Chicago and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Mark Potter)

U.S. administers 168.6 million doses of COVID-19 vaccines: CDC

(Reuters) – The United States has administered 168,592,075 doses of COVID-19 vaccines in the country as of Tuesday morning and distributed 219,194,215 doses, the U.S. Centers for Disease Control and Prevention said.

The tally is for Moderna, Pfizer/BioNTech, and Johnson & Johnson’s vaccines as of 6:00 a.m. ET on Tuesday, the agency said.

According to the tally posted on April 5, the agency had administered 167,187,795 doses of the vaccines, and distributed 207,891,395 doses.

The agency said 108,301,234 people had received at least one dose while 63,016,976 people are fully vaccinated as of Tuesday.

A total of 7,748,620 vaccine doses have been administered in long-term care facilities, the agency said.

(Reporting by Manojna Maddipatla in Bengaluru)

World Bank threatens to cut Lebanon’s vaccine aid over line-jumping

By Ellen Francis and Laila Bassam

BEIRUT (Reuters) – The World Bank threatened on Tuesday to suspend its multi-million dollar financing for Lebanon’s COVID-19 vaccination drive over politicians jumping the line.

The controversy, which echoed favoritism by elites in other countries as the world rushes to inoculate against the coronavirus, added to frustration among Lebanese over delays and violations in the vaccination campaign.

Local media and politicians said that some lawmakers got shots in parliament on Tuesday – despite not necessarily being in priority groups.

“Upon confirmation of violation, World Bank may suspend financing for vaccines and support for COVID19 response across Lebanon!!” the World Bank’s regional director Saroj Kumar Jha tweeted, saying it would be a breach of the national plan.

“I appeal to all, I mean all, regardless of your position, to please register and wait for your turn.”

The World Bank’s reallocation of $34 million has enabled Lebanon to receive its first two batches of about 60,000 Pfizer-BioNTech doses this month. The bank had said it would monitor the vaccine rollout and warned against favoritism in Lebanon, where decades of waste and corruption brought a financial meltdown and protests.

‘SELFISH’

One lawmaker, who asked not to be named, told Reuters that some older current and former lawmakers, as well as administrative staff, were vaccinated in the parliament hall.

“What’s the big deal? … They’re registered,” he said, referring to an online platform for vaccines. He added that doses were also sent last week to the Baabda palace for President Michel Aoun and about 16 others.

Aoun’s office said it would issue a statement.

Deputy parliament speaker Elie Ferzli, who at 71 is not in the first phase priority group, tweeted that he got a shot.

The doctor who heads Lebanon’s COVID-19 vaccination committee, Abdul Rahman Bizri, said it was unaware vaccines would be sent to parliament. “What happened today is unacceptable,” he told reporters.

Around the nation, outrage spread.

“My grandfather is an 85-year-old decent man suffering from heart and cardiovascular problems. My grandfather is a priority and he still did not get the vaccine,” tweeted Jad al-Hamawi.

“What are you? Bunch of hypocrites. Selfish. Criminals.”

Jonathan Dagher added on Facebook: “As our loved ones gasp for oxygen in COVID-19 wards, MPs cut the line today to take the vaccine.”

The health ministry did not immediately comment.

A surge in infections since January has brought Lebanon’s death toll over 4,300.

(Reporting by Ellen Francis and Laila Bassam; Additional reporting by Maha El Dahan; Editing by Andrew Cawthorne)