U.S. officials hope new mask advice drives uptick in COVID shots

WASHINGTON (Reuters) – With new federal guidance allowing people to ditch their masks in most places, it will be up to individuals to decide how to protect themselves now that vaccines are readily available, top U.S. health officials said on Friday.

“What we’re really doing is empowering individuals to make decisions about their own health,” U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said. “If you are vaccinated and you’re making the decision to take off your mask … you are safe. If you are unvaccinated, then you’ve made the decision to take that risk.”

She said officials were still encouraging unvaccinated people to get their shots as soon as possible to protect themselves and others against the novel coronavirus that is still circulating even as cases decline.

“People who are unvaccinated should not be taking off their masks,” Walensky told CBS News’ “CBS This Morning” program. In mixed settings where people aren’t wearing masks, “It is the vaccinated people who will be protected.”

Dr. Anthony Fauci, the nation’s top infectious disease official, echoed the idea that looser recommendations should encourage people to get their COVID-19 shots so they can shed their masks.

“Hopefully this will be an incentive for people to get vaccinated,” Fauci, U.S. President Joe Biden’s chief medical officer, told MSNBC in an interview.

The CDC’s official recommendation on Thursday that fully vaccinated people could avoid wearing face masks indoors in most places marked a significant shift toward normalcy for the country, where more than half a million have died in the pandemic over the past year.

There are caveats. The looser mask guidance does not apply to certain situations such as public transportation and prisons. There is also no approved U.S. COVID-19 vaccine for children aged 11 and younger.

Former Food and Drug Administration commissioner and now Pfizer board member Scott Gottlieb told CNBC he backed the new policy given that half the U.S. states had a low case rate of 10 per 100,000 people per day and that vaccination rates were high in many places.

“This is going to provide a pretty strong incentive for a lot of people who were on the fence about getting vaccinated to go out and get vaccinated. I would not be surprised if we see a pretty big bump up in the number of people going out to get vaccinated because now being vaccinated provides more value: you can go around without a mask,” he said.

Many states had already relaxed mask mandates and other restrictions in recent weeks as case loads dropped.

While some retail locations may keep masks as a requirement for another two weeks, masks will likely no longer be required there either as we get into June, Gottlieb said.

(Reporting by Susan Heavey and Caroline Humer; Editing by Howard Goller)

Fully vaccinated people can shed masks in most places and travel -U.S. CDC

By David Shepardson

WASHINGTON (Reuters) -The U.S. Centers for Disease Control and Prevention (CDC) on Thursday advised that fully vaccinated people do not need to wear masks outdoors and can avoid wearing them indoors in most places, updated guidance the agency said will allow life to begin to return to normal.

The CDC also said fully vaccinated people will not need to physically distance in most places. The agency also hopes the guidance will prod more Americans to get vaccinated.

President Joe Biden emerged at the White House for remarks without a mask. “I think it’s a great milestone, a great day,” he said.

“If you’re fully vaccinated and can take your mask off, you’ve earned the right to do something that Americans are known for all around the world: greeting others with a smile,” he said, flashing a brief smile himself.

CDC Director Rochelle Walensky said the new guidance just two weeks after its most recent update, was based on a sharp reduction in cases, expansion of vaccines to younger people and vaccine efficacy against coronavirus variants.

“We followed the science here,” Walensky said adding, “a coalescence of more science that has emerged just in the last week.”

Biden earlier shed his mask during a meeting with lawmakers, Republican Senator Shelly Moore Capito told reporters. “We heard all about it. The president took his off too,” she said.

Some journalists at the White House also shed their masks.

The CDC had faced criticism, even from public health officials, that it has been too cautious in its guidance. Critics have said people need to see more benefit of getting vaccinated in terms of returning to normal activities.

“In the past couple of weeks, we have seen additional data to show these vaccines work in the real world, they stand up to the variants, and vaccinated people are less likely to transmit the virus,” the agency said in a news release.

It added, “We needed to take the time to review the full body of evidence to get this right, and that’s how we came to this decision.”

‘NEED A REWARD’

Dr. William Schaffner, an infectious disease doctor at Vanderbilt University Medical Center, said he supports the new guidance that many had been calling for.

“People in state health departments and infectious disease doctors have been saying this for some time because they’re so impressed with the effectiveness of the vaccine, and also, they have the feeling that people who are vaccinated need a reward,” he said.

Republican Senator Susan Collins had been critical of the CDC’s delay in revising the guidance.

“Today’s announcement on masks, while overdue, is certainly a step in the right direction,” she said in a statement. “If people find they cannot do anything differently after a vaccine, they will not see the benefit in getting vaccinated.”

The revised guidance is a major step toward returning to pre-pandemic life, but the agency still recommends vaccinated people wear masks on planes and trains, and at airports, transit hubs, mass transit and in places like hospitals and doctor’s offices.

The U.S. government last month extended mask requirements across transportation networks through Sept. 13. Walensky said the CDC plans to soon issued updated guidance for transit.

The new guidance says vaccinated Americans can resume all travel, do not need to quarantine after international trips and do not need to be tested for COVID-19 if exposed to someone who is COVID-19 positive but asymptomatic.

However, Americans still face some international travel restrictions, including non-essential trips to Canada.

Masks became a political issues in the United States with then-President Donald Trump resisting mandating masks while President Joe Biden embraced masks and mandated them for transit hubs. Some U.S. states issued aggressive mask mandates while others declined or dropped them months ago.

The CDC said fully vaccinated people should still wear masks where required by federal, state, local, tribal or territorial laws, and abide by such rules and regulations, including from local businesses and workplace guidance.

In late April, the CDC said fully vaccinated people can safely engage in outdoor activities like walking and hiking without wearing masks, but recommended continuing to use face-coverings in public spaces where they are required.

Walensky said on Thursday immune-compromised individuals should consult doctors before shedding masks and emphasized people who have not been vaccinated should continue to wear them. She added vaccinated people who have COVID-19 symptoms should put masks back on.

(Reporting by David Shepardson; Additional reporting by Steve Holland in Washington and Julie Steenhuysen in Chicago; Editing by Franklin Paul and Bill Berkrot)

Explainer-Who decides if the world needs COVID-19 booster shots?

By Julie Steenhuysen and Kate Kelland

(Reuters) – Vaccine makers Moderna Inc and Pfizer Inc, with its German partner BioNTech, have been vocal in their view that the world will soon need COVID-19 booster shots to maintain high levels of immunity. What is less clear, however, is who should make that decision – and based on what evidence.

THE MODEL FOR FLU VACCINES

Public health officials have a well-coordinated mechanism, first established in 1952, for determining when seasonal flu vaccines should be updated to cope with fast-mutating strains of influenza.

The World Health Organization’s Global Influenza Surveillance and Response System gathers data collected by national health authorities on circulating flu strains and, twice a year, uses that information to select the strains manufacturers should include in seasonal shots for the Northern and Southern Hemispheres.

Some experts have suggested a similar model could be used to gather data on COVID-19 variants and advise drugmakers on what to include in vaccine updates.

However, another approach could be to mimic what happens with updates of many other infectious disease vaccines – where decisions are based primarily on what the drugmakers perceive is required. National health authorities are then free to assess clinical trial data and decide whether a particular version of a vaccine should be used in their country.

Currently, COVID-19 vaccine makers are taking this approach, making the call to develop and test variant-specific booster shots, and leaving it up to governments to buy them as they see fit.

WHAT EVIDENCE WILL BE NEEDED?

Some vaccine experts say there needs to be clear evidence that the current COVID-19 vaccines are failing to prevent infections and severe disease before countries embark on repeat nationwide vaccination campaigns.

They argue the decision on booster shots should be guided by data showing how vaccines perform in people in clinical trials and real-world settings, as well as in lab studies showing declining levels of antibodies in blood samples from vaccinated people.

So far, COVID-19 vaccine makers have shown that their shots offer strong protection for at least six months. But immunity may vary. Older people, for example, or those with compromised immune systems, may need boosters earlier than younger people with more robust immune systems.

Another important dataset known as “correlates of protection” – evidence from clinical trials showing the threshold level of antibodies required for vaccines to be protective – could help policymakers decide on whether boosters are needed, but this data is not yet available.

ADAPTED FOR A COVID-19 WORLD

Globally, the World Health Organization is putting together an expert advisory panel which would evaluate ongoing evidence on COVID-19 vaccine durability and emerging variants and then offer guidance for governments.

Although some experts have noted possible similarities with the global mechanism for updating flu vaccines, they also stress that it will need to be adapted for a COVID-19 world. More likely, they say, is that global guidance will be adapted by nations or regions to target local needs.

For example, the U.S. Centers for Disease Control and Prevention is developing its own risk assessment framework to determine what evidence is needed to recommend a modified vaccine.

The CDC and other U.S. health agencies have their own studies underway to assess vaccine efficacy, including in older populations and children, and monitor the impact of new variants.

In Britain, Public Health England and the National Institute for Biological Standards and Control are working with global agencies on an “Agility Project” to track and test the impact of viral mutations and new variants on COVID-19 vaccine development.

(Reporting by Kate Kelland in London and Julie Steenhuysen in Chicago; Editing by Michele Gershberg and Peter Graff)

U.S. CDC panel backs COVID-19 vaccine now cleared for adolescents

By Michael Erman and Manojna Maddipatla

(Reuters) -U.S. states are set to begin using the vaccine from Pfizer Inc and BioNTech SE to inoculate younger adolescents against COVID-19 after advisers to the U.S. Centers for Disease Control and Prevention (CDC) backed the plan in a unanimous vote on Wednesday.

The U.S. Food and Drug Administration on Monday authorized the vaccine for children aged 12 to 15, offering relief to parents eager to get their children back to schools and summer camps, and the action by the CDC group is an important, but not required, final seal of federal regulatory approval.

Some states, including Georgia, Delaware and Arkansas, began offering the vaccine to younger teens on Tuesday.

The Advisory Committee on Immunization Practices (ACIP), which provides recommendations to the CDC, voted 14-0 to back the vaccine, after reviewing trial evidence that showed no one in the 12-15 age group who received the vaccine got COVID-19, and there were no cases of Bell’s Palsy or severe allergic reactions.

Moreover, the vaccine produced robust antibody responses in the age group and showed 100% efficacy in the trial, with no cases of symptomatic COVID-19 among the fully vaccinated adolescents.

“This will provide protection for 12 to 15 year old’s,” said Dr. Henry Bernstein, a member of the advisory committee and professor of pediatrics at Zucker School of Medicine at Hofstra/Northwell. “It will decrease transmission within their family. It will contribute to community immunity, and it allows the kids to more safely go back to camps this summer, and back for in-person school.”

About a third of all Americans have been fully-vaccinated according to the CDC data. But the pace of vaccination has slowed in the recent weeks.

The rollout of a vaccine for adolescents should help further limit the spread of the virus at a time when more contagious variants are circulating, and could shorten the road to normalcy for Americans.

“I think we should be in full school, full in-person school, in the fall,” CDC Director Rochelle Walensky said at a CNBC health summit on Tuesday.

Children have been considered by health officials as being at a lower risk for severe COVID-19, but they can still spread the virus. More than 1.5 million cases have been reported among 12- to 17-year-olds, and as more adults become vaccinated, adolescents are accounting for a higher proportion of total cases.

Adjusted for underreporting, the working group estimated 22.2 million U.S. COVID-19 infections in those aged 5 to 17.

Pfizer is running a separate trial testing the vaccine in children as young as 6-months-old, and has said it expects data on its use in 2- to 11-year-olds in September. The 2,260 participants in the 12-to-15 age group – half of whom were given placebo – were tested as an expansion of Pfizer’s more than 46,000-person trial.

The committee will hear from Pfizer about the vaccine’s safety and efficacy in adolescents and will consider the views of a handful of CDC officials on its implementation.

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

U.S. CDC identifies 28 clotting cases after J&J vaccine

NEW YORK (Reuters) -The U.S. Centers for Disease Control and Prevention said on Wednesday it had identified 28 cases of serious, potentially life-threatening cases of blood clotting, among the more than 8.7 million people who had received the Johnson & Johnson COVID-19 vaccine.

The CDC said in a presentation that current evidence “suggests a plausible causal association” with the J&J vaccine and the cases of thrombosis with thrombocytopenia syndrome (TTS). TTS involves blood clots accompanied by a low level of platelets – the cells in the blood that help it to clot.

Three of the 28 have died. Previously, as of April 25, the CDC had reported 17 cases of clotting among nearly 8 million people given vaccines.

It said the events appear similar to what is being observed following administration of the AstraZeneca COVID-19 vaccine in Europe.

The syndrome does not appear to be associated with either of the COVID-19 vaccines produce by Pfizer Inc and BioNTech SA or Moderna Inc.

Most of the cases were among women aged 18 to 49, the CDC said. Rates among women aged 30-39 and 40-49 were particularly high, according to the presentation, at 12.4 cases per million and 9.4 cases per million, respectively.

Only six of the clotting events identified were in men.

(Reporting by Michael Erman; editing by John Stonestreet and Bernadette Baum)

One out of three Americans fully vaccinated for COVID-19, CDC says

(Reuters) – The United States has fully vaccinated 110,874,920 people for COVID-19 as of Friday morning, accounting for 33.4% of the population, the U.S. Centers for Disease Control and Prevention said on Friday.

The country has administered 254,779,333 doses of COVID-19 vaccines in the country and distributed 327,124,625 doses.

Those figures are up from the 251,973,752 vaccine doses the CDC said had gone into arms by May 6 out of 324,610,185 doses delivered.

The agency said 150,416,559 people had received at least one dose as of Friday.

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 Friday.

A total of 7,808,441 vaccine doses have been administered in long-term care facilities, the agency said.

(Reporting by Dania Nadeem in Bengaluru; Editing by Shailesh Kuber)

Global COVID-19 death toll more than double official estimates – IHME

(Reuters) – The COVID-19 pandemic has caused nearly 6.9 million deaths across the world, more than double the number officially recorded, a new analysis from the University of Washington’s Institute for Health Metrics and Evaluation (IHME) estimated.

Deaths go unreported as most countries only record those that occur in hospitals or of patients with a confirmed infection, the report showed.

The IHME is an independent health research organization that provides comparable measurement of the world’s health problems and has been cited in the past by the White House and its reports are watched closely by public health officials.

The reported COVID-19 mortality is strongly related to the levels of testing in a country, the IHME said.

“If you don’t test very much, you’re most likely to miss COVID deaths,” Christopher Murray, director of the Institute for Health Metrics and Evaluation, said in a briefing call with journalists.

IHME estimated total COVID-19 deaths by comparing anticipated deaths from all causes based on pre-pandemic trends with the actual number of all deaths caused during the pandemic.

In the United States, the analysis estimated COVID-19 related deaths of more than 905,000. Official figures from the U.S. Centers for Disease Control and Prevention on Wednesday estimated 575,491 deaths due to the novel coronavirus.

The CDC did not immediately respond to a Reuters request for comment on the report.

The report only includes deaths caused directly by the virus, not deaths caused by the pandemic’s disruption to healthcare systems and communities.

“Many countries have devoted exceptional effort to measuring the pandemic’s toll, but our analysis shows how difficult it is to accurately track a new and rapidly spreading infectious disease,” Murray said.

(Reporting by Dania Nadeem in Bengaluru; Editing by Sriraj Kalluvila)

CDC advances plan for resumption of U.S. passenger cruise operations

By David Shepardson

WASHINGTON (Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) has begun a key step for the eventual resumption of U.S. cruise industry operations by issuing new technical instructions.

In October, the CDC issued Conditional Sailing Order for operators, which acted as a guidance for a phased resumption of cruise ship passenger operations.

On Wednesday, it announced two new phases and said operators now have all necessary requirements needed “to start simulated voyages before resuming restricted passenger voyages and apply for a COVID-19 conditional sailing certificate to begin sailing with restricted passenger voyages.”

The CDC said on April 28 it was “committed” to the resumption of cruise industry passenger operations by mid-summer as it issued some clarifications of its earlier order.

The agency also released the COVID-19 Conditional Sailing Certificate application, “the final step before restricted passenger voyages.”

The new guidance includes eligibility and requirements for conducting a trial voyage in preparation for restricted passenger voyages and for CDC cruise ships inspections during simulated and restricted passenger voyages.

Once cruise ships operators receive approved COVID-19 Conditional Sailing Certificate applications, they will be permitted to sail with passengers.

The Cruise Lines International Association, which represents Carnival Corp, Norwegian Cruise Line and Royal Caribbean Cruises, said Wednesday it was reviewing the CDC’s latest instructions. The association said last week it was optimistic that CDC “clarifications show positive progression—and, importantly, a demonstrated commitment to constructive dialogue, which is key to restarting cruising.”

The group added “plenty of work remains in order to achieve our mutual goal of responsible resumption from U.S. ports this summer.”

Florida and Alaska have filed a lawsuit seeking to force the CDC to immediately allow the resumption of cruise operations.

The CDC said COVID-19 vaccines “play a critical role in the safe resumption of passenger operations, but not all cruise ship operators have announced plans to mandate passenger vaccinations.”

The agency said it “recommends that all port personnel and travelers (passengers and crew) get a COVID-19 vaccine.”

(Reporting by David Shepardson; Editing by Aurora Ellis)

U.S. judge throws out pandemic-related moratorium on evicting renters

By Jonathan Stempel

(Reuters) -A federal judge on Wednesday threw out the U.S. Centers for Disease Control and Prevention’s nationwide moratorium on evictions, delivering a setback to Americans hit hard financially by the coronavirus pandemic.

Washington-based U.S. District Judge Dabney Friedrich said the “plain language” of a federal law called the Public Health Service Act, which governs the response to the spread of communicable diseases such as COVID-19, blocked the CDC’s moratorium.

The moratorium had been scheduled to lapse on June 30.

The CDC did not immediately respond to a request for comment.

The National Association of Realtors welcomed the judge’s decision, saying a better solution would be to help tenants pay rent, taxes and utility bills.

“With rental assistance secured, the economy strengthening and unemployment rates falling, there is no need to continue a blanket, nationwide eviction ban,” the group said.

Friedrich’s decision, which the government could appeal, provides temporary relief for landlords struggling with delinquent tenants and vacancies.

At least 43 states and Washington, D.C., have imposed their own temporary halts on residential or business evictions, though the protections are far from uniform.

A separate eviction and foreclosure moratorium for federally financed housing from the U.S. Department of Housing and Urban Development expires on June 30.

The CDC moratorium was issued last September, during former President Donald Trump’s administration, and had been extended three times, most recently in March under President Joe Biden’s administration.

It covered renters who expected to earn less than $99,000 a year, or $198,000 for joint filers, or who reported no income, or received stimulus checks. Renters must swear they are doing their best to make partial rent payments, and that evictions would likely leave them homeless or force them into “shared” living quarters.

Landlords and real estate trade groups that challenged the moratorium in court said the CDC lacked the power to impose it, and unlawfully took away their right to deal with delinquent tenants.

Friedrich, a Trump appointee, said there was “no doubt” Congress intended to empower the CDC to combat COVID-19 through a range of measures, such as quarantines, but not a moratorium.

“The court recognizes that the COVID-19 pandemic is a serious public health crisis that has presented unprecedented challenges for public health officials and the nation as a whole,” Friedrich wrote. “The pandemic has triggered difficult policy decisions that have had enormous real-world consequences. The nationwide eviction moratorium is one such decision.”

Other courts have been divided over the moratorium, with some also finding the CDC exceeded its authority, though none formally blocked its enforcement.

According to the White House, one in five renters had fallen behind on rent as of January, while the CDC has said more than 4 million adults who are behind feared imminent eviction.

The National Association of Realtors told the Biden administration in January that 40 million Americans had fallen behind on rent, with $70 billion of missed payments by the end of 2020.

(Reporting by Tim Ahmann and David Shepardson in Washington, Tom Hals in Wilmington, Delaware and Jonathan Stempel in New York; Editing by Will Dunham)

U.S. FDA set to authorize Pfizer COVID-19 shot for ages 12-15 early next week – NYT

(Reuters) – The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency’s plans.

An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.

Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine’s emergency use authorization is ongoing, but did not provide further details.

The vaccine has already been cleared in the United States for people aged 16 and above.

Pfizer declined to comment on the NYT report.

The U.S. Centers for Disease Control (CDC) Director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.

If an approval for the 12-15 year old’s is granted, the CDC’s vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents, the report added.

A potential approval of the vaccine would boost the country’s immunization drive and help allay fears of parents anxious to protect their children from COVID-19.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year old’s, with data from Moderna’s trial expected to come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

(Reporting by Trisha Roy in Bengaluru; Editing by Devika Syamnath)