Moderna begins study of COVID-19 vaccine in kids

(Reuters) – Moderna Inc has begun dosing patients in a mid-to-late stage study of its COVID-19 vaccine, mRNA-1273, in children aged six months to less than 12 years, the company said on Tuesday.

The study will assess the safety and effectiveness of two doses of mRNA-1273 given 28 days apart and intends to enroll about 6,750 children in the United States and Canada.

The vaccine has already been authorized for emergency use in Americans who are aged 18 and older.

In a separate study which began in December, Moderna is also testing mRNA-1273 in adolescents between 12 and 18 years old.

The latest study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber)

U.S. administers nearly 111 million doses of COVID-19 vaccines: CDC

The United States has administered 110,737,856 doses of COVID-19 vaccines and distributed 142,918,525 doses in the country as of Tuesday morning, the U.S. Centers for Disease Control and Prevention (CDC) 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 March 15, the agency had administered 109,081,860 doses of the vaccines, and distributed 135,847,835 doses.

The agency said 72,135,616 people have received at least one dose, while 39,042,345 people were fully vaccinated as of Tuesday.

A total of 7,569,120 vaccine doses have been administered in long-term care facilities, the agency said.

(Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli)

Germany, Italy, France to halt AstraZeneca shots, further hitting EU vaccination campaign

By Thomas Escritt and Stephanie Nebehay

BERLIN/GENEVA (Reuters) – Germany, France and Italy said on Monday they would stop administering the AstraZeneca COVID-19 vaccine after several countries reported possible serious side-effects, throwing Europe’s already struggling vaccination campaign into disarray.

Denmark and Norway stopped giving the shot last week after reporting isolated cases of bleeding, blood clots and a low platelet count. Iceland and Bulgaria followed suit and Ireland and the Netherlands announced suspensions on Sunday.

The moves by some of Europe’s largest and most populous countries will deepen concerns about the slow rollout of vaccines in the region, which has been plagued by shortages due to problems producing vaccines, including AstraZeneca’s.

Germany warned last week it was facing a third wave of infections, Italy is intensifying lockdowns and hospitals in the Paris region are close to being overloaded.

German Health Minister Jens Spahn said that although the risk of blood clots was low, it could not be ruled out.

“This is a professional decision, not a political one,” Spahn said adding he was following a recommendation of the Paul Ehrlich Institute, Germany’s vaccine regulator.

France said it was suspending the vaccine’s use pending an assessment by the EU medicine regulator due on Tuesday. Italy said its halt was a “precautionary and temporary measure” pending the regulator’s ruling.

Austria and Spain have stopped using particular batches and prosecutors in the northern Italian region of Piedmont earlier seized 393,600 doses following the death of a man hours after he was vaccinated. It was the second region to do so after Sicily, where two people had died shortly after having their shots.

The World Health Organization appealed to countries not to suspend vaccinations against a disease that has caused more than 2.7 million deaths worldwide.

“As of today, there is no evidence that the incidents are caused by the vaccine and it is important that vaccination campaigns continue so that we can save lives and stem severe disease from the virus,” WHO spokesman Christian Lindmeier said.

The United Kingdom said it had no concerns, while Poland said it thought the benefits outweighed any risks.

“UNUSUAL” SYMPTOMS

AstraZeneca’s shot was among the first and cheapest to be developed and launched at volume since the coronavirus was first identified in central China at the end of 2019 and is set to be the mainstay of vaccination programs in much of the developing world.

Thailand announced plans on Monday to go ahead with the Anglo-Swedish firm’s shot after suspending its use on Friday but Indonesia said it would wait for the WHO to report.

The WHO said its advisory panel was reviewing reports related to the shot and would release its findings as soon as possible. But it said it was unlikely to change its recommendations, issued last month, for widespread use, including in countries where the South African variant of the virus may reduce its efficacy.

The European Medicines Agency (EMA) has also said there was no indication the events were caused by the vaccination and that the number of reported blood clots was no higher than seen in the general population.

The handful of reported side-effects in Europe have upset vaccination programs already under pressure over slow rollouts and vaccine skepticism in some countries.

The Netherlands said on Monday it had seen 10 cases of possible noteworthy adverse side-effects from the AstraZeneca vaccine, hours after the government put its vaccination program on hold following reports of potential side-effects in other countries.

Denmark reported “highly unusual” symptoms in a 60-year-old citizen who died from a blood clot after receiving the vaccine, the same phrase used on Saturday by Norway about three people under the age of 50 it said were being treated in hospital.

“It was an unusual course of illness around the death that made the Danish Medicines Agency react,” the agency said in a statement late on Sunday.

One of the three health workers hospitalized in Norway after receiving the AstraZeneca shot had died, health authorities said on Monday, but there was no evidence that the vaccine was the cause. They said they would continue their probe and that no more suspected cases had been reported since Saturday.

AstraZeneca said earlier it had conducted a review covering more than 17 million people vaccinated in the European Union and the UK which had shown no evidence of an increased risk of blood clots.

Investigations into potential side-effects are complicated as the history of each case and circumstances surrounding a death or illness are examined. Austrian authorities have said their review of the AstraZeneca batch will take about two weeks.

The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries.

The WHO said that as of March 12, more than 300 million doses of COVID-19 vaccines had been administered around the world with no deaths found to have been caused by any of them.

(Reporting by Panarat Thepgumpanat in BANKOK and Andreas Rinke and Paul Carrel in BERLIN, Angelo Amante in ROME, Christian Lowe in PARIS, Toby Sterling in AMSTERDAM, Jacob Gronholt-Pedersen in COPENHAGEN and Stanley Widianto in JAKARTA; writing by Philippa Fletcher; editing by Nick Macfie)

U.S. government to ship 18.5 million doses of COVID vaccine this week, White House says

(Reuters) – The White House said on Tuesday that the government will distribute around 18.5 million doses of COVID-19 vaccines this week, fewer than last week because no new doses of Johnson & Johnson’s vaccine are ready to be sent out.

White House press secretary Jen Psaki said at a news briefing that the U.S. government plans to distribute 15.8 million doses of the Pfizer/BioNTech and Moderna vaccine to states, tribes and territories, along with 2.7 million doses going to pharmacies.

Last week, the U.S. government distributed over 21 million doses of all three vaccines. That included over 3.5 million doses of the newly authorized J&J vaccine.

J&J’s manufacturing has been slower than expected, and the company was not expected to be able to deliver any doses of its vaccine this week. It is expected to resume shipments of the vaccine later in March.

As of Tuesday morning, more than 123 million doses of the vaccines had been distributed in the United States and 93.7 million shots had been administered, according to data from the U.S. Centers for Disease Control and Prevention.

(Reporting by Michael Erman, Editing by Rosalba O’Brien)

U.S. administers 93.7 million doses of COVID-19 vaccines: CDC

(Reuters) – The United States has administered 93,692,598 doses of COVID-19 vaccines in the country as of Tuesday morning and distributed 123,232,775 doses, the U.S. Centers for Disease Control and Prevention said on Tuesday.

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 March 8, the agency had administered 92,089,852 doses of the vaccines, and distributed 116,378,615 doses.

A total of 7,419,240 vaccine doses have been administered in long-term care facilities, the agency said.

(Reporting by Trisha Roy in Bengaluru)

In Brazil’s Amazon, isolated indigenous people welcome COVID vaccine

By Leonardo Benassatto and Ueslei Marcelino

YAUARETÊ, Brazil (Reuters) – An army helicopter flew to two isolated indigenous villages in Brazil’s Amazon jungle this week with a welcome cargo – coronavirus vaccines.

The Hupda communities lined up to get their shots.

Traditional medicine prescribed by a shaman is highly respected here, but there was no resistance to receiving the vaccine by China’s Sinovac Biotech.

“We are grateful for the vaccination, so we will not catch the disease,” said Hupda chieftain Jorge Pires in the village of Santo Antanasio, near the Colombian border and a 25-minute helicopter flight from the nearest military outpost.

Following criticism by indigenous leaders that echoed internationally last year that their vulnerable communities were being “decimated” by COVID-19, Brazil’s Health and Defense ministries have mounted a vaccination campaign reaching remote reservations and villages.

So far 265,244 indigenous people have had a first dose, and 124,063 the second dose, of 400,000 covered by the ministry’s indigenous health service Sesai.

According to the service, 50,000 indigenous people have been infected and 589 have died from COVID-19.

That does not include half of Brazil’s 800,000 plus indigenous population not covered by Sesai because they have moved off traditional lands and reservations.

Brazil is battling a COVID-19 outbreak that is worsening, with record deaths reported in the last three days, reaching 1,910 dead in 24 hours on Wednesday. So far, 260,000 people have died and 10.8 million infected, the second-deadliest after the United States.

In the second village of Taracuá Igarapé, there have been no cases of COVID-19 thanks to its isolation, but preventing coronavirus from taking hold is paramount to protecting indigenous communities that live under one roof and cannot practice social distancing.

The challenge of reaching 20,000 indigenous people living in a jungle area the size of Portugal is enormous, and requires helicopter travel, because travel by meandering rivers takes days, said Army Colonel Sylvio Doktorczyk.

“When we talk about Amazonia, everything is superlative, including the difficulties! Particularly the great distances and long rivers,” the colonel heading the mission said.

It was a return visit to the two villages to inoculate those that missed the first dose because they were out hunting or fishing, and to give others their second shot of CoronaVac.

“My people liked to have the vaccine. My community like the vaccine and like when medical people come here,” said Jovino Pinoa, after getting his second shot.

(Reporting by Leonardo Benasatto and Ueslei Marcelino, writing by Anthony Boadle; editing by Diane Craft)

Some Republican governors stand by mask mandates as Texas and Mississippi accelerate reopening

By Gabriella Borter

(Reuters) – While Texas and Mississippi announced complete rollbacks of their states’ COVID-19 mitigation measures this week, several governors of other Republican states have made clear they are not abandoning their mask mandates despite political pressure.

The sharp decline of new daily COVID-19 cases and the rollout of vaccines in the United States have prompted state and local governments to ease business restrictions in recent weeks, with movie theaters set to open at limited capacity in New York and indoor dining resuming in San Francisco on Friday.

However, the decline in cases plateaued last week with new infections rising in 29 out of 50 states compared with the prior week. Texas saw a 69% rise in cases in the week ended Feb. 28.

Few of the rollbacks have been as sweeping as in Texas, where Governor Greg Abbott on Tuesday said the state’s mask mandate would be lifted and most businesses could open at full capacity next week.

The move drew immediate criticism from some politicians and public health experts who have urged caution while the nation’s vaccination program is still underway.

President Joe Biden said on Wednesday that decisions to end the required wearing of masks – such as those made by Texas and Mississippi – amounted to “Neanderthal thinking” given the ongoing deaths being caused by the pandemic.

“I think it’s a big mistake. Look, I hope everybody’s realized by now, these masks make a difference,” he told reporters.

Public health experts agree face coverings are essential to slowing the spread of the virus, which has killed more than half a million Americans. But over the last year, resistance to public health measures in the United States, especially mask-wearing, has become politicized, with many Republican states enacting fewer and looser COVID-19 protocols than Democratic states.

In some Republican-led states, including Florida and South Dakota, there has never been a statewide mask mandate. In others, like Alabama and Ohio, mask mandates remain in effect.

Including the upcoming change in Texas, 34 states mandate that residents wear face masks in public, along with the District of Columbia and Puerto Rico.

In Ohio, U.S. Senate candidate Josh Mandel on Wednesday called on Republican Governor Mike DeWine to follow Texas’ lead and repeal the statewide mask order. The governor quickly rejected the idea.

“Ohio will be keeping its mask mandate to protect Ohioans who have yet to receive the vaccine. Vaccine supply is increasing, and there is light at the end of the tunnel, but the virus is still here and the pandemic is still ongoing today,” a spokesman for DeWine told Reuters in an email.

Governor Jim Justice of West Virginia, a Republican, said on Wednesday he was not ready to ease any restrictions, including an indoor mask mandate.

“All businesses must continue to follow the safety guidelines,” Justice said.

Abbott’s executive order in Texas will lift all mask requirements statewide as of March 10 and forbid local authorities from penalizing residents who do not wear face coverings. It will remove all restrictions on businesses in counties without a high number of hospitalizations.

Local officials can still apply limits to businesses where hospitalizations remain high, according to the order, but are prohibited from mandating that they operate at less than 50% capacity.

As of Monday, Texas was seeing about 7,500 new cases per day on a seven-day average, according to Reuters data, and it was ranked 47th in the list of states that have vaccinated the highest percentage of their populations.

Mississippi Governor Tate Reeves, a Republican, on Tuesday also lifted his state’s mask order and removed all restrictions on businesses.

But Louisiana Governor John Bel Edwards, a Democrat in a majority Republican state, doubled down on his state’s mask order even as it increased capacity to 75% at restaurants and retail businesses on Wednesday.

“Louisiana’s mask mandate is still in place,” Edwards tweeted. “As we vaccinate more and more people, masks are still our most effective tool in stopping the spread of COVID-19 and saving lives.”

(Reporting by Gabriella Borter, Peter Szekely, Jarrett Renshaw and Carl O’Donnell; Editing by Colleen Jenkins and Lisa Shumaker)

COVID safety measures still essential even as U.S. boosts vaccine supply: White House

By Carl O’Donnell and Jarrett Renshaw

NEW YORK (Reuters) – U.S. states need to “rally together” to maintain safety measures like social distancing and mask-wearing even as the federal government helps ramp up the production and delivery of vaccines, the White House said on Wednesday.

White House senior adviser Andy Slavitt said the federal government is planning to spend $100 million to help the joint partnership between Merck & Co and rival Johnson & Johnson accelerate vaccine production.

The infusion will help Johnson & Johnson ramp up its production of vaccines, Slavitt said. The company was contracted to deliver 200 million doses to the federal government by the end of May and roughly a billion doses globally by end-2021.

“Over time we believe Merck will be able to double the capacity of Johnson & Johnson,” Slavitt said.

Slavitt said while the increased production is good news, he urged states like Texas to reconsider recent decisions to lift mask mandates and allow businesses to fully open without restrictions.

There are health officials in every state who feel “now is the wrong time to lift the mask mandate,” Slavitt said. “Hopefully, the country will continue to rally together on this front.”

(Reporting By Jarrett Renshaw and Carl O’Donnell; Editing by Sonya Hepinstall)

U.S. CDC says trend of decline in COVID-19 cases may be stalling

WASHINGTON (Reuters) – The head of the U.S. Centers for Disease Control and Prevention said on Friday that a recent decline in COVID-19 cases may be stalling, a development she described as concerning while urging that restrictions to fight the virus remain in place.

Dr. Rochelle Walensky told reporters the CDC was watching the concerning data closely.

The White House on Friday also urged companies to join efforts to help fight the pandemic by requiring mask wearing by employees and educating customers.

Andy Slavitt, a senior adviser on the White House’s COVID-19 response team, listed a number of companies that were taking measures to help with the pandemic fight and urged more to join.

Ford and the Gap were producing and donating millions of masks, he said, while Best Buy, Target and Dollar General were giving workers paid time off to get vaccines.

The White House is working on a broad campaign to educate Americans about the vaccine as it seeks to bring the pandemic that has killed more than 500,000 people in the United States under control.

President Joe Biden on Thursday noted concerns that later this spring supply of the vaccines would outstrip demand because of vaccine hesitancy.

(Reporting by Jeff Mason, Carl O’Donnell and Lisa Lambert; Editing by Chizu Nomiyama)

COVID-19 vaccine makers tell Congress U.S. supply will surge soon

By Michael Erman and Manojna Maddipatla

NEW YORK (Reuters) – COVID-19 vaccine makers told Congress on Tuesday that U.S. supplies should surge in the coming weeks due to manufacturing expansions and new vaccine authorizations.

Executives from Pfizer Inc, Moderna Inc and Johnson & Johnson – speaking at a hearing at the U.S. House of Representatives – said they would be able to supply enough vaccine to fully inoculate 130 million people in the United States by the end of March.

The drugmakers also reaffirmed their commitments to supply more than enough doses necessary to vaccinate all Americans by the end of July.

Pfizer Chief Business Officer John Young said it was plausible that there could be a surplus of vaccine in the United States sometime in the second quarter of this year.

“We certainly hope that we’re going to be in a position where every eligible adult will be able to receive vaccinations,” Young said.

Around 44.5 million people in the United States had received at least one dose of two-shot vaccines developed by Pfizer and BioNTech or Moderna, as of Tuesday morning.

Johnson & Johnson’s single-dose vaccine will be considered by an outside advisory committee to the U.S. Food and Drug Administration later this week, and emergency use authorization could come shortly afterward.

Richard Nettles, Vice President of Medical Affairs at J&J’s Janssen Pharmaceuticals unit, said the company would be able to ship nearly 4 million doses of its COVID-19 vaccine upon authorization and 20 million doses by the end of March.

Additional doses could also come from AstraZeneca Plc and from Novavax Inc, which are currently running clinical trials of their experimental vaccines.

An AstraZeneca executive said the drugmaker could supply doses necessary to vaccinate another 25 million people by the end of April if their vaccine is authorized by U.S. regulators.

(Reporting by Michael Erman; Editing by Bill Berkrot)