Exclusive: Biden set to ban most travel to U.S. from India to limit COVID-19 spread

By David Shepardson

WASHINGTON (Reuters) – U.S. President Joe Biden is expected to impose new travel restrictions on India starting Tuesday in light of the COVID-19 epidemic, barring most non-U.S. citizens from entering the United States, a White House official told Reuters.

The new restrictions are on the advice of the U.S. Centers for Disease Control and Prevention and are imposed “in light of extraordinarily high COVID-19 case loads and multiple variants circulating in India,” the official said. A formal announcement is expected on Friday and the policy will take effect on Tuesday, May 4 at 12:01 am ET (0401 GMT).

Biden in January issued a similar ban on most non-U.S. citizens entering the country who have recently been in South Africa. He also reimposed an entry ban on nearly all non-U.S. travelers who have been in Brazil, the United Kingdom, Ireland and 26 countries in Europe that allow travel across open borders.

The policy means most non-U.S. citizens who have been in one of those countries – and now India – within the last 14 days are not eligible to travel to the United States. China and Iran are also both covered by the policy.

Second only to the United States in total infections, India has reported more than 300,000 new cases daily for nine days in a row, hitting another global record of 386,452 on Friday.

Total deaths have surpassed 200,000 and cases are nearing 19 million – nearly 8 million since February alone – as virulent new strains have combined with “super-spreader” events such as political rallies and religious festivals.

Medical experts say real numbers may be five to 10 times higher than the official tally.

Other countries have imposed similar travel restrictions on India, including the United Kingdom, Germany, Italy and Singapore, while Canada, Hong Kong and New Zealand have suspended all commercial travel with India.

Permanent U.S. residents and family members and some other non-U.S. citizens are permitted to return to the United States under the order.

(Reporting by David Shepardson, Editing by Rosalba O’Brien)

Fully vaccinated people can unmask outdoors in some cases: U.S. CDC

(Reuters) – Fully vaccinated people can safely engage in outdoor activities like walking and hiking without wearing masks but should continue to use face-coverings in public spaces where they are required, U.S. health regulators said on Tuesday.

The updated health advice comes as more than half of all adults in the United States have now received at least one dose of COVID-19 vaccine, according to the U.S. Centers for Disease Control and Prevention (CDC).

“The release of these new guidelines is a first step at helping fully vaccinated Americans resume activities they had stopped doing because of the pandemic, while being mindful of the potential risk of transmitting the virus to others,” the CDC said.

Wearing face masks has been considered by experts as one of the most effective ways of controlling virus transmission. With most COVID-19 transmission occurring indoors, and vaccinations on the rise, the use of masks outdoors has been under public debate for weeks in the United States as Americans look to enjoy the benefits of being fully vaccinated.

New COVID-19 cases have dropped 16% in the last week as the U.S. surpassed 140 million people having received at least one shot of authorized vaccines from Pfizer/BioNTech, Moderna or Johnson & Johnson’s one-dose vaccine.

This was the biggest percentage drop in weekly new cases since February, according to a Reuters analysis of state and county data.

SMALL OUTDOOR GATHERINGS

The agency said fully-vaccinated Americans can safely dine outdoors with friends from multiple households at restaurants and attend small outdoor gatherings with a mixture of fully vaccinated and unvaccinated people.

CDC continues to recommend masking for crowded outdoor events such as parades and sporting events and indoor visits to the hair salon, shopping malls, movie theaters and houses of worship.

The agency classified activities as “red,” “yellow” and “green” based on level of safety for unvaccinated people.

It said unvaccinated people can also walk and run unmasked with household members outdoors safely and attend small outdoor gatherings with fully vaccinated family and friends.

Data on whether vaccinated people can spread infection to those who did not receive their shots is limited and the CDC warned that people should evaluate risk to friends and family before going out without masks.

This is an update to the CDC’s guidance, which in March said people who have been fully vaccinated against COVID-19 can meet without masks indoors in small groups with others who also have been inoculated.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Caroline Humer and Bill Berkrot)

U.S. administers 230.8 million doses of COVID-19 vaccines – CDC

(Reuters) – The United States has administered 230,768,454 doses of COVID-19 vaccines in the country as of Monday morning, the U.S. Centers for Disease Control and Prevention said on Monday.

The figure is up from the 228,661,408 vaccine doses the CDC said had gone into arms by Sunday out of 290,692,005 doses delivered.

The agency said 140,969,663 people had received at least one dose while 95,888,088 people are fully vaccinated as of Monday.

The CDC tally includes two-dose vaccines from Moderna and Pfizer/BioNTech, as well as Johnson & Johnson’s one-shot vaccine as of 6:00 a.m. ET on Monday.

A total of 7,791,592 vaccine doses have been administered in long-term care facilities, the agency said.

The number of vaccine doses delivered remained at 290,692,005, as of Monday morning as shipments are not always sent on Sundays, according to the CDC.

(Reporting by Trisha Roy in Bengaluru)

J&J stands ready to roll out COVID-19 vaccine in Europe as regulators weigh risks

By Manas Mishra and Carl O’Donnell

(Reuters) -Johnson & Johnson said on Tuesday it stands ready to resume rolling out its COVID-19 vaccine in Europe, where the region’s medical regulator said the benefits of the shot outweigh the risk of very rare, potentially lethal blood clots.

Use of the company’s one-dose vaccine was temporarily halted by U.S. regulators last week after the rare brain blood clots combined with a low blood platelet count were reported in six women, prompting the company to delay its rollout in Europe.

Europe’s health regulator, the European Medicines Agency, on Tuesday recommended adding a warning about blood clots with low blood platelet count to the vaccine’s product label, but said the benefits of the one-dose shot outweigh its risks.

J&J earlier on Tuesday said it was set to resume vaccinations in Europe and was working with European countries to resume ongoing clinical trials for its shot.

“It’s an extremely rare event. We hope by making people aware as well as putting clear diagnostic and therapeutic guidance in place that we can restore the confidence in our vaccine,” said J&J’s Chief Scientific Officer Paul Stoffels.

The United States is also reviewing a handful of potential cases of severe side effects in addition to those that led to the pause.

“The outcome of the vaccine review is important for overall global vaccination efforts, given J&J’s vaccine does not have the extreme cold storage requirements of the mRNA vaccines,” Edward Jones analyst Ashtyn Evans said, referring to vaccines from Moderna Inc and Pfizer Inc with partner BioNTech SE.

Meanwhile, J&J is working with U.S. regulators to get clearance for its Baltimore-based vaccine production plant, owned by Emergent BioSolutions Inc, and expects feedback in the coming days. Emergent shut down production at its plant earlier this month after manufacturing errors ruined millions of J&J doses in March.

“We are remediating what we need to remediate. We think that will lend itself to a positive outcome,” said J&J Chief Financial Officer Joseph Wolk during a call to discuss quarterly results. He said J&J “should know more in the next couple of days.”

Nearly 8 million people had received the J&J vaccine in the United States prior to the halt.

J&J said it would fulfill its commitments to ship 200 million doses in Europe and 100 million in the United States.

The company said it recorded $100 million in COVID-19 vaccine sales. J&J has said the vaccine will be available on a not-for-profit basis until the end of the pandemic.

An advisory committee to the U.S. Centers for Disease Control and Prevention is expected to meet on Friday to address the pause after it delayed making any recommendations in a meeting last week and called for more data.

Johnson & Johnson reported first-quarter earnings that exceeded Wall Street expectations and raised its dividend payouts to shareholders.

The company said it expects a big improvement in sales from its medical device business in the second quarter of 2021 compared with a year earlier, when COVID-19 lockdowns took a toll.

J&J slightly raised its full-year adjusted profit forecast and now sees earnings of $9.42 to $9.57 per share, up from its prior view of $9.40 to $9.60 per share.

Total sales rose 7.9% to $22.32 billion, beating estimates of $21.98 billion.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Carl O’Donnell in New York; Editing by Anil D’Silva and Bill Berkrot)

New U.S. COVID cases fall 0.4% last week, after rising for four weeks

(Reuters) – New cases of COVID-19 in the United States fell 0.4% last week after rising for four weeks in a row, according to a Reuters analysis of state and county data.

Health experts say new cases have plateaued at a high level as more infectious variants of the virus offset progress made in vaccinations. The country logged nearly 70,000 new cases per day in the week ended April 18, compared with 55,000 new cases a day in March and about 30,000 new cases this time last year.

Michigan continued to lead the states, with nearly twice as many new cases per 100,000 people last week as Rhode Island and New Jersey, the states with the next highest rates of infection based on population.

The average number of COVID-19 patients in hospitals rose 5% to more than 41,000 across the country, increasing for a third week in a row, according to the Reuters analysis.

Deaths from COVID-19, which tend to lag infections by several weeks, fell 2.8% last week, excluding a backlog of deaths reported by Oklahoma, according to the Reuters analysis. Including the backlog, reported deaths fell by 27%.

Cumulatively, nearly 568,000 people have died from the coronavirus pandemic, or one in every 576 U.S. residents.

Vaccinations plateaued at 3.1 million shots per day last week, after setting records the previous seven weeks. U.S. health regulators called for a pause in administering the Johnson & Johnson vaccine last week due to reports of brain blood clots in six women who received the shot out of some 7 million vaccinated.

As of Sunday, 40% of the U.S. population has received at least one dose of a vaccine, and 25% was fully vaccinated, according to the Centers for Disease Control and Prevention.

Biden administration to invest $1.7 billion to fight COVID-19 variants

By Nandita Bose

WASHINGTON (Reuters) – The Biden administration on Friday said it will invest $1.7 billion to help states and the U.S. Centers for Disease Control and Prevention fight COVID-19 variants that are rapidly spreading across the United States.

The investment, which will be part of President Joe Biden’s $1.9 trillion American Rescue Plan, will improve detection, monitoring, and mitigation of these variants by scaling up genomic sequencing efforts – a key step in containing the spread, the White House said.

“The original strain of COVID-19 comprises only about half of all cases in America today. New and potentially dangerous strains of the virus make up the other half,” the White House said in a statement.

In early February, U.S. laboratories were only sequencing about 8,000 COVID-19 strains per week. Since then the administration has invested nearly $200 million to increase genomic sequencing to 29,000 samples per week – an effort that will get a boost with the new funding.

The investment will be broken down into three areas: $1 billion to expand genomic sequencing, $400 million to help build six research centers for genomic epidemiology and $300 million to build a national bioinformatics infrastructure – which will help build a repository of data.

The first portion of the funding will be distributed in early May and the next round will be invested over the coming several years, the White House said.

The White House also offered a state-by-state breakdown of the funds with California receiving over $17 million, Texas over $15 million and Florida over $12 million.

A White House official said on Thursday the United States is preparing for the possibility that a booster shot will be needed between nine to 12 months after people are initially vaccinated against COVID-19.

Also, Pfizer Inc Chief Executive Albert Bourla said people will “likely” need a third booster dose of COVID-19 vaccines within 12 months and could need annual shots.

The United States had administered 198,317,040 doses of COVID-19 vaccines in the country as of Thursday morning and distributed 255,400,665 doses, according to the CDC.

(Reporting by Nandita Bose in Washington; Editing by Steve Orlofsky)

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)

UK variant of COVID-19 is now most common strain in United States: CDC

By Susan Heavey and Carl O’Donnell

WASHINGTON (Reuters) – The highly contagious variant of COVID-19 first discovered in the United Kingdom has become the most common strain of the virus in the United States as cases continue to climb, a top U.S. health official said on Wednesday.

The strain, known as B.1.1.7, was identified in Britain last fall and has since been detected in 52 jurisdictions in the United States, U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky told reporters at a White House briefing.

U.S. public health officials have urged Americans to get vaccinated as soon as possible in part to prevent new variants of the novel coronavirus from spreading.

The United States has also detected cases of a variant first discovered in South Africa that is thought to be resistant to some COVID-19 vaccines and treatments. That strain has been found in 36 U.S. jurisdictions, according to federal data last updated on Tuesday.

The United States is administering about 3 million COVID-19 vaccine doses per day on average over the past week, up 8% over the previous seven-day average, Walensky said.

Vaccine supply has increased significantly in the United States in recent weeks as Johnson & Johnson has begun making millions of doses of its recently authorized shots. Pfizer/BioNTech and Moderna have also recently boosted their vaccine production capacity.

Still, daily U.S. cases of novel coronavirus are averaging 63,000 over the past seven days, up 2.3% from the previous seven-day average, Walensky said.

Walensky said that the CDC has identified a number of COVID-19 outbreaks tied to youth sporting events and that communities experiencing high case counts should avoid holding such events. Testing should also happen twice a week, she said.

White House COVID-19 adviser Andy Slavitt also told reporters that the U.S. government is expanding its community health center program, which it set up in recent weeks to help get vaccines into underserved communities.

(Reporting by Susan Heavey, Jeff Mason and Carl O’Donnell; Editing by Lisa Shumaker)

U.S. delivering about 3 million COVID-19 vaccines per day, up 8%: CDC director

WASHINGTON (Reuters) – The United States has delivered about 3 million COVID-19 vaccine doses per day on average over the past week, up 8% over the previous 7-day average, U.S. Centers for Disease Control and Prevention Director Rochelle Walensky said on Wednesday.

Still, daily U.S. cases of novel coronavirus are averaging 63,000 over the past seven days, up 2.3% from the previous 7-day average, she told reporters at a White House briefing.

(Reporting by Susan Heavey, Jeff Mason and Carl O’Donnell)

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)