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

By Manojna Maddipatla and Michael Erman

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

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

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

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

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

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

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

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

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

BioNTech says vaccine repeats beat devising new one for now

By Ludwig Burger

FRANKFURT (Reuters) -BioNTech said that repeat shots of its COVID-19 vaccine, of which more than a billion doses have now been supplied worldwide, was a better strategy than tailoring the product it developed with Pfizer to new variants.

The German biotech firm said that offering a third dose of its established two-shot vaccine remained the best response to concerns over waning immune protection in the face of the highly contagious Delta variant, as worse strains may emerge.

BioNTech said the more than one billion supply tally as per July 21 was up from 700 million-plus doses it announced in June.

This compares with AstraZeneca saying last month that it and manufacturing partner Serum Institute of India had supplied a billion doses of its vaccine globally.

Based on delivery contracts signed for more than 2.2 billion doses so far, BioNTech said in a statement detailing its second quarter earnings that it expects to accrue 15.9 billion euros ($18.7 billion) in revenue from the vaccine this year, up from a May forecast of 12.4 billion euros.

That includes sales, milestone payments and a share of gross profit in its partners’ territories, BioNTech added.

Pfizer late last month raised its forecast for its share of 2021 vaccine sales to $33.5 billion and said at the time it believes people will need a third dose of the shot.

Pfizer and BioNTech’s decision in early July to seek authorization for a third dose drew criticism from U.S. health regulators, who said there was not yet enough data to show booster shots are needed.

U.S. health agencies have since discussed additional doses for people with compromised immune systems, while Germany and France said they would roll out a third dose for the most vulnerable from September.

That jars with a call by the World Health Organization to use doses instead to jump-start vaccination campaigns in poorer nations which have so far been left behind.

BioNTech Chief Executive Ugur Sahin said that although work was ongoing to adjust the vaccine to variants it was not clear whether yet another version of the pathogen would supplant the now prevalent Delta variant.

“Making a decision at the moment might turn out to be wrong in three or six months if another variant is dominating,” Sahin said during an analyst call.

Chief Medical Officer Oezlem Tuereci said lab experiments had shown that a third shot of the established product generated neutralizing antibodies against a range of strains and that the antibody boost was above the one following a second dose.

Still, the company reiterated plans to start testing a vaccine adjusted to the Delta variant on humans this month, part of a “comprehensive strategy to address variants.”

($1 = 0.8509 euros)

(Reporting by Ludwig BurgerEditing by Chizu Nomiyama and Alexander Smith)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What you need to know about the coronavirus right now

(Reuters) – Here’s what you need to know about the coronavirus right now:

Sydney’s outbreak throws spotlight on vaccine rollout

Australia’s New South Wales state on Friday reported its biggest daily rise in new COVID-19 cases this year, prompting a tighter lockdown in Sydney and a request for additional vaccine doses that was rebuffed by other state leaders.

Australia reported another record day for vaccination with almost 200,000 doses delivered in one day. Prime Minister Scott Morrison, who on Thursday apologized for the slow pace of inoculation, said the latest data signaled the country’s vaccination rollout had turned a corner.

New Zealand will pause its quarantine-free travel arrangement with Australia for at least eight weeks starting Friday night, Prime Minister Jacinda Ardern said.

Philippines to bar travel from Malaysia, Thailand

The Philippines will suspend travel from Malaysia and Thailand, as well as tighten restrictions in the Manila area, in a bid to prevent the spread of the contagious Delta variant of the coronavirus, the presidential spokesperson said on Friday.

The travel restriction will take effect from Sunday and run to the end of July.

Vietnam’s Ho Chi Minh City extends lockdown

Vietnam will extend a strict lockdown in Ho Chi Minh City until Aug. 1, state media reported on Friday.

After successfully containing the virus for much of the pandemic, Vietnam has been facing a complicated outbreak of the virus, with southern business hub Ho Chi Minh City and surrounding provinces accounting for most new infections.

Banking and securities services in the city will be reduced to minimal levels, while unnecessary construction projects will be suspended.

Taiwan to ease restrictions as cases drop

Taiwan will ease its COVID-19 restrictions next week, the government said on Friday, as rapidly falling case numbers give authorities confidence to further lower the alert level.

Taiwan imposed restrictions on gatherings, including closing entertainment venues and limiting restaurants to take-out service, in mid-May following a spike in domestic cases after months of no or few cases apart from imported ones.

While some of those curbs were eased this month, the so-called level 3 alert has been in force and is due to end on July 26.

Pfizer says U.S. govt buying 200 mln more doses

Pfizer and German partner BioNTech said on Friday the U.S. government had purchased 200 million additional doses of their COVID-19 vaccine and had the option to buy an updated version of the vaccine targeting new variants of the virus.

The announcement brings the total number of the doses to be supplied to the United States to 500 million, out of which roughly 208 million doses have already been delivered.

A longer gap between doses of Pfizer’s vaccine leads to higher overall antibody levels than a shorter gap, a British study found on Friday, but there is a sharp drop in antibody levels after the first dose.

Sinopharm’s shot offers weaker protection among elderly

Sinopharm’s COVID-19 vaccine was less effective in offering protection against the disease among the elderly, according to the results of a Hungarian study.

The study of 450 participants who had received two doses of the vaccine showed measurable antibody levels were present in about 90% of people under the age of 50, but the protection reduced as age increased.

(Compiled by Linda Noakes; Editing by Joe Bavier)

U.S. donation of 1.4 million COVID-19 vaccine doses arrives in Afghanistan

By Doyinsola Oladipo

(Reuters) – A U.S. donation of more than 1.4 million doses of the Johnson & Johnson COVID-19 vaccine arrived in Afghanistan on Friday, the first of two shipments this month, the U.N. children’s agency UNICEF said in a statement.

A second shipment of vaccines donated by the United States through the COVAX global sharing program will bring the total to 3.3 million doses, UNICEF said. The U.S. vaccine donations come as U.S. military forces withdraw from Afghanistan, ending a 20-year war in the country.

The deliveries are part of President Joe Biden’s pledge to share 80 million vaccine doses globally, most through COVAX, which is run by the Gavi Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, the World Health Organization and UNICEF.

“These vaccines arrive at a critical time for Afghanistan as the country faces a difficult surge in COVID-19 infections,” said UNICEF Representative in Afghanistan, Hervé Ludovic De Lys.

Over 1,200 new infections were reported in Afghanistan on July 8th down from a record peak of 1,853 new cases on June 21st, according to the Reuters COVID-19 tracker. Less than four percent of the Afghan population is vaccinated, UNICEF said.

“As many countries face vaccine supply challenges, the dose-sharing mechanism is a rapid way to close the immediate supply gap,” De Lys said. “I hope that other governments will step up and share their doses, supplies and therapeutics to protect those most in need.”

(Reporting by Doyinsola Oladipo, editing by Michelle Nichols and David Gregorio)

COVAX aims to resolve Venezuela COVID-19 vaccine roadblocks after Maduro ‘ultimatum’

CARACAS (Reuters) – The COVAX vaccine-sharing facility is aiming to overcome roadblocks to the shipment of coronavirus shots to Venezuela “as soon as possible,” a spokesman for the GAVI alliance said on Tuesday.

The comments from GAVI, the Vaccine Alliance which runs COVAX with the World Health Organization, came after President Nicolas Maduro on Sunday said he was giving the COVAX system an “ultimatum” to send doses to the crisis-stricken South American country or return the money Venezuela had already paid.

Officials from the OPEC nation said in June that several payments to cover the $120 million fee have been made, but that the final four payments have been blocked by Swiss bank UBS. Maduro’s allies have attributed that to U.S. sanctions aimed at ousting him from the presidency.

“We are working to resolve this matter as quickly as possible,” a GAVI spokesperson said.

Washington in 2019 blacklisted Venezuela’s state oil company, central bank and other government institutions, though it exempts humanitarian transactions from the sanctions.

Still, the measures have left many banks wary of processing even authorized Venezuela-related transactions.

Venezuela’s COVAX payments are not subject to any sanctions, but pose compliance problems for UBS because the government has not satisfactorily spelled out to the bank exactly what the payment is for, a person familiar with the matter said, adding that UBS will execute the transaction as soon as the open questions are clarified.

Venezuela’s information ministry did not immediately respond to a request for comment.

Several of the payments to COVAX were made by local Venezuelan banks on the government’s behalf, Reuters reported last month.

Venezuela has received 3.5 million vaccine doses from allies Russia and China, and is also conducting trials for Cuba’s Abdala vaccine.

(Reporting by Mayela Armas and Michael Shields; Writing by Luc Cohen; Editing by Bill Berkrot)

Moderna’s COVID-19 vaccine shows promise against Delta variant in lab study

(Reuters) -Moderna Inc’s COVID-19 vaccine showed promise against the Delta variant first identified in India in a lab study, with a modest decrease in response compared to the original strain, the drugmaker said on Tuesday.

The study was conducted on blood serum from eight participants obtained one week after they received the second dose of the vaccine, mRNA-1273.

The vaccine provoked an antibody response against all the variants tested, according to Moderna, but one that remained inferior in all cases to the vaccine’s neutralizing activity against the original coronavirus strain first found in China.

The vaccine was far more effective in producing antibodies against the Delta variant than it was against the Beta variant first identified in South Africa, the data showed.

Against three versions of the Beta variant, the vaccine-elicited neutralizing antibodies reduced six-to-eight fold compared to those produced against original strain, while modest 3.2 to 2.1 fold reductions were seen for lineages of the variant first identified in India including Delta and Kappa.

“These new data are encouraging and reinforce our belief that the Moderna COVID-19 vaccine should remain protective against newly detected variants,” Chief Executive Stéphane Bancel said.

Earlier in the day, India granted permission to drugmaker Cipla Ltd to import Moderna’s vaccine to the country for restricted use.

The drugmaker’s shares were up 5.5% at $235.39 in mid-day trading.

Moderna has submitted the data as a preprint to the website bioRxiv ahead of peer review.

(Reporting by Mrinalika Roy in Bengaluru; Editing by Arun Koyyur)

Factbox: Back to pubs, gyms and movies: plotting the return to normal

(Reuters) – As the COVID-19 vaccine rollout gains momentum, many countries are planning a gradual return to normal, opening borders and letting people back into restaurants, shops and sports venues after more than a year of on-off lockdowns.

Here are some of their plans, in alphabetical order:

BRITAIN

Britain expects to fully reopen pubs, restaurants, nightclubs and other hospitality venues on July 19.

Non-essential retailers in England reopened on April 12 along with pubs and restaurants operating outdoors. Indoor hospitality, cinemas, theatres and sports halls reopened on May 17 with capacity restrictions. Britain also resumed international travel, with quarantine rules still in place for most arrivals.

CANADA

Canadians and permanent residents who have received two vaccination doses will be exempt from quarantine when returning to the country from July 5.

COLOMBIA

Colombia on June 3 approved reopening most large events like concerts and sports matches with 25% capacity for cities where intensive care units occupancy rates are below 85%.

From July 15, international travelers no longer need to present a negative PCR test and in-person classes will resume for pre-school children to university students.

FRANCE

France ended a national night-time curfew on June 20, 10 days earlier than initially scheduled, while face masks will soon no longer be required outdoors.

Nightclubs can re-open from July 9.

On June 9, France fully reopened its cafes, bars, and restaurants. Sports halls, spas, swimming pools, and casinos also resumed operation.

Shops, museums, cinemas and theatres reopened on May 19.

GERMANY

Germany eased restrictions on those fully vaccinated or recovered from the virus from May 9, lifting curfews and quarantine rules as well as the obligation to provide a negative test result to visit a hairdresser, a zoo or to go shopping.

Since May 12, travelers have been able to enter the country without the need to quarantine, except those arriving from risk areas.

General travel warning for risk regions that have a seven-day coronavirus incidence of below 200 will be lifted starting July 1.

Germany is on target for outdoor concerts this summer, with social distancing and COVID-19 testing for attendees, and fans should be back at soccer matches in August.

A rule which forces companies to allow working from home will be lifted on June 30.

INDIA

On June 14, all New Delhi’s shops and malls re-opened although bars, gyms, salons, cinemas and parks remain shut.

Federally protected monuments opened to tourists on June 16.

Some businesses in Tamil Nadu were allowed to bring back 50% of employees and salons and liquor shops reopened. Bus services resumed on June 21.

In Bengaluru, the capital of Karnataka state, authorities allowed the partial reopening of businesses, though strict night and weekend curfews remained in place.

From June 7, the state of Maharashtra allowed malls, movie theatres, restaurants and offices to open regularly in districts where the positivity rate has fallen below 5%.

ISRAEL

Israel reopened borders to tourists on May 23. Under a pilot program, it gave the green light to visits by 20 groups of between five and 30 tourists from countries including the United States, Britain and Germany. It hopes to let individual tourists in from July.

From June 15, citizens may stop wearing masks indoors, except for unvaccinated patients or staff in medical facilities, people en route to quarantine, and passengers on commercial flights.

ITALY

Italian coffee bars, restaurants, cinemas and theatres partially reopened in most regions on April 26. Indoor service at restaurants resumed from June 1.

Italy lifted quarantine restrictions for travelers arriving from European and Schengen countries, as well as Britain and Israel, from May 15.

A nightly curfew was scrapped from June 21 and wearing masks outdoors will not be mandatory from June 28.

JAPAN

Japan eased curbs in nine prefectures including Tokyo from June 20, ahead of the Summer Olympics due to start in late July. Bars and restaurants now can serve alcohol until 7 p.m., but restaurants are still asked to shut by 8 p.m. Certain measures such as spectator limits at major events remain in place.

NETHERLANDS

Most group size limits will be lifted from June 26, as long as people can keep at least 1.5 meters apart. People will not be required to wear face masks anywhere except for public transport and airports, where distancing is not possible.

POLAND

Poland reopened shopping centers, hotels, restaurants cinemas, theatres and concert halls in May. Indoor dining, indoor sports facilities and swimming pools reopened on May 28.

Large indoor events with up to 50 people were allowed from May 28, a number that was tripled on June 6.

From June 13, churches can be filled up to 50% of capacity. Limits for concerts and sports events will be raised from June 26 to 50% of seats, while hotels can be filled to up to 75% capacity.

People who have been vaccinated are not counted in the capacity limits.

QATAR

From May 28, Qatar allowed leisure, education centers, restaurants, gyms, pools and salons to operate at limited capacity, but bans on weddings, conferences and exhibitions remain in place.

Local and international sporting events can take place with fully vaccinated fans in open-space venues at 30% capacity.

SINGAPORE

Singapore allowed dining at restaurants to resume from June 21, though it limits diners to groups of two. Gyms and fitness studios resumed indoor exercise for groups of up to two people.

SOUTH KOREA

From June 14, South Korea allows up to 4,000 people to attend concerts and other cultural shows. Sports stadiums can operate at 30% to 50% capacity, depending on the districts.

From July 1, fully vaccinated overseas visitors can apply for exemptions from mandatory two-week quarantine if they are visiting family or travelling for the purpose of business, academic or public interest.

Masks will no longer be required outdoors from July.

SPAIN

Curfews were lifted across most of Spain on May 9. From May 24, it allowed travel from low-risk non-EU countries without a negative PCR test. From June 7, vaccinated people from anywhere in the world could enter.

The country will lift a blanket obligation to wear masks outdoors from June 26.

THAILAND

Thailand said on June 16 it aims to fully reopen to visitors within 120 days. Some tourism centers will resume earlier, starting with a pilot reopening from July 1 on its most popular island, Phuket.

TURKEY

Sunday lockdowns and weekday curfews, as well as public transport restrictions, will be lifted on July 1. Music events, including concerts, will then be allowed until midnight.

UNITED STATES

On May 3, New York City allowed drinking at an indoor bar for the first time in months, days after Mayor Bill de Blasio said the city should reopen in full on July 1.

On June 15, the state of New York lifted all state-mandated restrictions, including capacity limits of 50% for retailers and 33% for gyms. Mitigation measures are still required in public transit and healthcare settings.

New York joined California, where most remaining crowd-capacity limits and physical distancing requirements were also lifted on June 15.

New York City and Los Angeles plan to fully reopen schools from September.

Chicago and Illinois fully reopened on June 11.

The states of New Jersey and Connecticut lifted most capacity restrictions on businesses, including retail stores, food services and gyms, on May 19.

Florida Governor Ron DeSantis on May 3 signed an executive order to end all local emergency measures.

(Compiled by Vladimir Sadykov, Dagmarah Mackos and Federica Urso; Editing by Milla Nissi and Gareth Jones)

CDC says U.S. young adults less likely to take COVID-19 vaccine

(Reuters) – Younger adults are seeking out COVID-19 vaccines at a slower rate than older adults, and if that pace of vaccination continues through August, vaccine coverage among younger adults will not reach levels achieved with older adults, U.S. Centers for Disease Control and Prevention (CDC) reported on Monday.

The agency said more work is needed to increase vaccination rates among younger adults to reduce COVID-19 hospitalizations and deaths.

Of the 57% American adults who received at least one vaccine dose by May 22, coverage was highest among people 65 or older and lowest among people aged 18 to 29, according to an analysis of vaccine rates published on Monday in the CDC’s Morbidity and Mortality Weekly Report.

The observations are based on vaccination data reported to the agency from Dec. 14, 2020 to May 22, 2021.

Younger Americans also are more likely to be reluctant to get vaccinated because of concerns over vaccine safety and effectiveness, the agency reported separately on Monday, citing data from household surveys conducted from March to May, 2021.

The lowest rates of vaccination were among lower income, non-Hispanic Black adults aged 18–39 with lower levels of education who lacked health insurance and live outside of major cities, according to the report.

It found that nearly one in four adults aged 18-39 said they would probably or definitely not get vaccinated during the survey period.

Vaccination of Americans began in December last year and early efforts were focused on specific high-risk groups, such as healthcare workers and older adults. This was later expanded to all American adults aged 18 and older, beginning April 19.

Offering workplace vaccination programs, paid leave for vaccination and mobile, walk-in clinics with flexible hours could help improve vaccination rates among younger adults, the CDC reported.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Julie Steenhuysen and Aurora Ellis)

New York governor lifts remaining COVID-19 restrictions, calls it a ‘momentous day’

By Maria Caspani and Jonathan Allen

NEW YORK (Reuters) -New York is lifting all state-mandated coronavirus restrictions after reporting that 70% of the state’s adults have received at least one dose of COVID-19 vaccine, Governor Andrew Cuomo announced on Tuesday.

“It is an important milestone, and we’re going to keep pushing to do more,” Cuomo told a news conference, adding that the state would continue to encourage more New Yorkers to get vaccinated.

Restrictions across commercial and social settings will be lifted immediately. Cuomo said some limitations based on guidelines from the U.S. Centers for Disease Control and Prevention would remain in place, with mitigation measures still required in public transit and healthcare settings.

Cuomo, whose state was the epicenter of the U.S. COVID-19 public health crisis last year, also said individuals and businesses could still choose to adopt some precautions.

The governor, who won praise in the early days of the pandemic for his televised news conferences but later became entangled in accusations of sexual misconduct, abuse of power and allegations of mishandling nursing homes during the crisis, made a triumphant entrance at the World Trade Center in New York City on Tuesday to mark what he called a “momentous day.”

“New York State has fully vaccinated a larger share of adults than any other big state in the country,” he told a cheering crowd that included first responders and hospitality workers.

On Tuesday night, fireworks all across the state will celebrate the milestone, Cuomo announced, and the Empire State Building and other state landmarks will be lit in blue and gold, New York’s colors.

Most U.S. states have moved to ease or lift coronavirus restrictions as the virus abates and vaccinations progress.

New York joined California, where restrictions including physical distancing, mask requirements and capacity limits for restaurants, stores and other businesses that cater to consumers end on Tuesday.

(Reporting by Maria Caspani and Jonathan Allen in New York, Editing by Will Dunham, Chizu Nomiyama and Bill Berkrot)