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)

White House to shift COVID-19 vaccine to states with more need

WASHINGTON (Reuters) -The White House told U.S. states on Tuesday they can no longer carry over unordered doses of their weekly COVID-19 vaccine allocations and that unused doses will instead be shifted to states with greater demand, the Washington Post reported.

COVID-19 vaccines are currently allocated state by state based on population – a formula the Biden administration held to even as some states such as Michigan saw recent surges of the coronavirus.

But White House Coronavirus Task Force Coordinator Jeff Zients told the Washington Post in an interview that the change in allocation reflects the next phase in the White House’s efforts to inoculate the population.

“There is a need to add more flexibility to the current system,” he told the news outlet.

The shift also comes as new U.S. COVID-19 cases fell for the third week in a row. About 30.5% of the U.S. population, or about 101,407,318 people, have been fully vaccinated as of last week.

Representatives for the White House could not be immediately reached for comment on the report.

(Reporting by Susan Heavey; Editing by Tim Ahmann and Nick Macfie)

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)

Return the favor: South Korea looks to U.S. for COVID-19 vaccine aid

By Sangmi Cha

SEOUL (Reuters) – South Korea hopes the United States will help it tackle a shortage of coronavirus vaccine in return for test kits and masks Seoul sent to Washington earlier in the pandemic, the foreign minister said on Wednesday.

The government has drawn fire from the media for not doing enough to secure enough vaccines early, with just 3% of the population inoculated, due to tight global supply and limited access.

“We have been stressing to the United States that ‘A friend in need is a friend indeed,'” the minister, Chung Eui-yong, told reporters at the Kwanhun Club of South Korean journalists.

He said South Korea had airlifted Washington a large volume of coronavirus test kits and face masks in the early stages of the pandemic “in the spirit of the special South Korea-U.S. alliance,” despite tight domestic supply at the time.

“We are hoping that the United States will help us out with the challenges we are facing with the vaccines, based on the solidarity we demonstrated last year.”

The allies were in talks, added Chung, who also flagged South Korea’s potential contribution to preserving a global semiconductor supply chain U.S. President Joe Biden is keen to maintain.

Diplomatic efforts have not yielded any concrete steps, however, as the talks with Washington are still in an early stage, health ministry official Son Young-rae told reporters.

Opposition lawmaker Park Jin urged more aggressive vaccine diplomacy, calling for the government to invoke its free trade pact (FTA) with Washington to secure pharmaceutical products.

“The government needs to be more proactive,” Park told Reuters.

“The FTA provides us a legal base to demand (vaccines) as it stipulates the two countries’ commitment to promoting the development of, and facilitating access to, pharmaceutical products.”

The U.S. embassy in Seoul did not immediately reply to a Reuters’ request for comment.

About 1.77 million people in South Korea have had their first dose of the AstraZeneca Plc or Pfizer vaccines. The low rate compares with a 40% vaccination rate in the United States, according to Reuters data.

Tuesday’s 731 new coronavirus infections, up from 549 cases a day earlier, took South Korea’s tally to 115,926, with 1,806 deaths.

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)

India to allow COVID-19 vaccines for all adults as cases surge

By Neha Arora and Anuron Kumar Mitra

NEW DELHI (Reuters) – India will let all citizens over 18 have COVID-19 vaccinations from May 1, the government said on Monday, as the health system creaked under the weight of record-high cases and the capital region of New Delhi ordered a lockdown.

Facing growing criticism over its handling of the second wave of the pandemic, Prime Minister Narendra Modi’s administration said vaccine manufacturers would have to supply 50% of doses to the federal government and the rest to state governments and the open market at a pre-declared price.

Daily COVID-19 cases in India jumped a record 273,810 on Monday, and deaths rose a record 1,619 to 178,769. Hospitals have a shortage of beds, oxygen and key medicines, and infections have passed 15 million, the world’s second highest total after the United States.

The New Delhi region ordered a six-day lockdown starting Monday night after its chief minister said the health system was unable to take more patients in big numbers.

“If a lockdown isn’t implemented now, the situation will go beyond control,” Chief Minister Arvind Kejriwal told a virtual media briefing on Monday.

Criticism of Modi’s administration has increased as he continued to address large state election rallies and let Hindu devotees congregate for a festival.

Kejriwal had said on Sunday that fewer than 100 critical care beds were available in the city of New Delhi, which has a population of more than 20 million people, and social media were flooded with complaints.

New Delhi joined 13 other Indian states that have decided to impose restrictions, curfews or lockdowns in their cities, including the richest state of Maharashtra and Modi’s home state of Gujarat, where the industrial city of Ahmedabad is also grappling with a shortage of beds.

Hong Kong said late on Sunday that the Asian financial hub will suspend flights from India, Pakistan and the Philippines from Tuesday for two weeks.

Britain has put India on a travel “red-list” and Prime Minister Boris Johnson cancelled a planned trip to India next week.

As of Monday, India had administered nearly 123.9 million vaccine doses – the most in the world after the United States and China, though it ranks much lower in per capita vaccination.

The current vaccination process is controlled by the federal government. Liberalizing it would augment vaccine production and availability, and attract new domestic and international vaccine manufacturers, the government said in its statement.

“It would also make pricing, procurement, eligibility and administration of vaccines open and flexible, allowing all stakeholders the flexibility to customise to local needs and dynamics,” it said.

(Reporting by Neha Arora in New Delhi, Anuron Kumar Mitra and Nivedita Bhattacharjee in Bengaluru; additional reporting by Sumit Khanna in Ahmedabad and Aftab Ahmed in New Delhi; Editing by Christian Schmollinger, Michael Perry, Nick Macfie and Timothy Heritage)

Native health providers drive Alaska’s vaccination success story

By Yereth Rosen

ANCHORAGE, Alaska (Reuters) Despite its sprawling geography and often-inhospitable climate, Alaska ranks among the top U.S. states for getting COVID-19 vaccine into the arms of its residents, and its indigenous population has played a major role in that achievement.

With a history and culture deeply shaped by deadly outbreaks of disease that have periodically ravaged remote corners of their subarctic homeland, Alaska Natives have aggressively led the way on inoculations against COVID-19 for the state as a whole.

Through their federally recognized sovereign powers, Alaska Native tribes has secured larger vaccine supplies from the U.S. Indian Health Service (IHS) than the state government has obtained for itself, said Tiffany Zulkosky, a Yup’ik and state legislator from the southwestern Alaska community of Bethel.

As a result, tribal health organizations primarily serving indigenous communities – representing just 18% of the state’s 730,000 inhabitants – have played an outsized role in the state’s overall vaccine campaign.

Acting Anchorage Mayor Austin Quinn-Davidson, who is white, tweeted a photo of herself getting a shot courtesy of a Native organization in early March.

“Alaska is leading the country in vaccinations because of the incredible work and generosity of our Tribal partners,” she wrote.

By early April, more than 42% of all Alaska residents aged 16 and older had received at least a first dose of a COVID-19 vaccine, ranking near the top among states with the highest rates of inoculation per capita and by percentage of population.

The percentages run higher in regions dominated by Native populations, which have been particularly hard hit by the pandemic.

Although precise figures are hard to come by, a significant number of shots received by the general public come from the IHS supply or are being administered by tribal networks, said Zulkosky, a vice president of the Yukon-Kuskokwim Health Corp, which serves a region the size of Oregon.

Besides the impetus of achieving herd immunity, “there is that cultural value of sharing and taking care of one another,” she said.

In some extremely remote Native villages vaccination rates are now approaching 90 percent, according to state data. Tribal providers prioritized those villages for early vaccine delivery because they tend to have limited medical services and often lack modern plumbing and sewage systems.

‘OVERWHELMING HAPPINESS’

Karma Ulvi, tribal leader in the onetime gold rush outpost of Eagle, home to about 120 people – half of them Alaska Natives – on the Yukon River near the Canadian border, said the arrival of vaccines there came as a great relief.

By early April, nearly the entire community was vaccinated, Ulvi told Reuters, stressing the importance of immunization in a place where only about three in every 20 households have running water, making good hand hygiene difficult.

“There was just an overwhelming happiness among people here that received it,” she said of the vaccines.

With limited phone and internet service and no wintertime road access, the nearest hospital is at least three hours away by aircraft. Even then “it’s very hard to be in touch with the plane if there’s an accident or if someone is sick,” Ulvi said.

To reach such communities, tribal health providers used bush planes, boats, snow machines and even sleds.

The campaign hearkened back to the famous 1925 Serum Run, when a dog-sled relay delivered life-saving diphtheria medicine to Nome. The Yukon-Kuskokwim Health Corp dubbed its COVID-19 vaccine-delivery system Project Togo, after a celebrated lead dog in the storied serum run.

CULTURAL SURVIVAL

Alaska Natives imposed some of the nation’s earliest and most robust lockdowns, mask mandates and other rules to curb the pandemic. The virus reached rural sites nonetheless, with some devastating results. Indigenous people accounted for 37 percent of COVID-19 deaths in the state last year, more than twice their proportion of the population, according to the state epidemiology office.

The Native COVID-19 death rate was nearly four times that for white Alaskans, according to state data.

The present-day tribal response is also colored by memories of past trauma, including the 1918 influenza pandemic that shattered Native communities, virtually wiping out entire villages.

The “Great Flu” is a particularly vivid cultural loss, said PJ Simon, chairman of the Tanana Chiefs Conference, a consortium of Athabascan tribes in interior Alaska.

“Some families will never know their last name because they all died,” he told Reuters. “People were reeling. Sometimes just a kid or a boy or girl survived and the rest of the family died and everyone else was trying to get back to normal, much like we are trying to do right now.”

Pfizer, BioNTech seek U.S. emergency nod for COVID-19 vaccine in adolescents

By Michael Erman and Mrinalika Roy

(Reuters) – Pfizer Inc and its German partner BioNTech SE on Friday asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15.

The vaccine is currently authorized for emergency use in the United States for people aged 16 and up. The companies said on Friday that they requested an expansion of the authorization from the U.S. Food and Drug Administration to include the younger age group.

In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year old’s in a clinical trial.

It is unclear how long the regulator will take to review the data from the trial, although U.S. Centers for Disease Control director Rochelle Walensky told ABC news on Thursday that she expects the vaccine to be authorized for 12 to 15 year olds by mid-May.

It is also unclear whether the regulator will require a meeting of the independent advisory board that recommended the original authorization in order for the companies to receive the nod in the younger age group.

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

Inoculating children and young people is considered a critical step toward reaching herd immunity and taming the pandemic, according to many experts.

Pfizer and BioNtech said they plan to ask other regulatory authorities globally to allow the use of their vaccine in 12- to 15-year old’s in the coming days.

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. puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca

By Shubham Kalia

(Reuters) – The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official said on Saturday.

J&J said it was “assuming full responsibility” of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May.

In a separate statement late Sunday, Emergent said it expects to align with the U.S. government and AstraZeneca to ramp down manufacturing for AstraZeneca’s COVID-19 vaccine at its Baltimore plant.

The Department of Health and Human Services has also increased Emergent’s order by $23 million for expansion of production specific to J&J’s vaccine doses, Emergent added.

“The $23 million will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent’s Baltimore Bayview facility,” the company said.

The Department of Health and Human Services facilitated the move, the health official said in an email, asking not to be named due to the sensitivity of the matter.

AstraZeneca, whose vaccine has not been approved in the United States, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.

White House officials did not immediately respond to a request for comment.

The development, first reported by the New York Times, further hampers AstraZeneca’s efforts in the United States. The government has criticized the drugmaker for using outdated data in the results of its vaccine trial. It later revised its study.

Workers at the Emergent BioSolutions plant several weeks ago conflated ingredients for the J&J and AstraZeneca vaccines, the Times said earlier in the week. J&J said at the time the ruined batch had not advanced to the fill-and-finish stage.

The government’s move to have the facility make only the J&J single-dose vaccine is meant to avoid future mix-ups, the Times said, citing two senior federal health officials.

The top U.S. infectious disease doctor told Reuters on Thursday the country may not need AstraZeneca’s vaccine even if it wins approval.

The United States has loan deals to send Mexico and Canada roughly 4 million doses of the AstraZeneca vaccine, made at its U.S. facility.

(Reporting by Shubham Kalia, Vishal Vivek and Aakriti Bhalla in Bengaluru; Additional reporting by Steve Holland in Washington; Editing by William Mallard and Stephen Coates)