Pfizer, Moderna get EU nod for boosting mRNA vaccine output

A medic places two vials of COVID-19 coronavirus vaccines (from left to right): Pfizer-BioNTech and Moderna, on a table before administering doses at a Clalit Health Services Medical Centre in east Jerusalem on Aug 10, 2021. (HAZEM BADER / AFP)

BERLIN / ATHENS / NAIROBI / LONDON / KIGALI / RABAT / WASHINGTON / VANCOUVER / PARIS / MOSCOW / GHENT, Belgium – Europe's medicines regulator has approved additional manufacturing sites for mRNA-based coronavirus vaccines developed by Pfizer-BioNTech, and Moderna to help boost production amid a resurgence in infections.

The European Medicines Agency (EMA) said on Tuesday its human medicines committee had approved a site at Saint Remy sur Avre in France for making the Pfizer-BioNTech vaccine, Comirnaty.

The Delpharm-operated site will help provide up to 51 million additional doses of Comirnaty in 2021, the EMA said.

The regulator also said it had approved a new manufacturing line at BioNTech's site at Marburg in Germany, which would help boost capacity for the vaccine's active substance by about 410 million doses this year.

The European Union has been trying to boost and protect supplies after a rocky start to its vaccination campaign by bringing more facilities online and paying more for new COVID shots.

The EMA also gave its go-ahead for an additional site at Bloomington, Indiana in the United States for Moderna's vaccine and several other locations involved in testing and packaging.

The Bloomington site is operated by contract drug manufacturer Catalent Inc.

Belgium

Llama antibodies could soon be playing a role in the global fight against COVID-19, if clinical trials being conducted by a Belgian biomedical start-up live up to their early promise.

Researchers from the VIB-UGent Center for Medical Biotechnology in Ghent say antibodies extracted from a llama called Winter have blunted the virulence of coronavirus infections, including variants, in laboratory testing.

The technology, which would supplement rather than replace vaccines by protecting people with weaker immune systems and treating infected people in hospital, is a potential "game-changer", said Dominique Tersago, chief medical officer of VIB-UGent spin-off ExeVir.

Unusually small, llama antibodies are able to bind to specific part of the virus's protein spike and "at the moment we're not seeing mutations of a high frequency anywhere near where the binding site is," she said.

The antibodies also showed "strong neutralization activity" against the highly infectious Delta variant, she added.

Researchers expect clinical trials in healthy volunteers, started last week in partnership with Belgian pharmaceutical company UCB, along with those in hospitalised patients, to be similarly effective.

Brazil

The most populous city in Latin America will begin requiring residents to have received at least one dose of a COVID-19 vaccine in order to enter restaurants, bars and public events.

Sao Paulo’s new “vaccine passport” rule announced by Mayor Ricardo Nunes mandates that some businesses must ensure the vaccination status of each patron in order to avoid fines, which Nunes said “won’t be cheap,” in a press conference Monday. 

Vaccination status can be proved by showing either the card given when the dose is administered or a QR code created via a web app that is expected to be launched Friday, the mayor said.

The effective date of the new rule has not yet been disclosed. 

Over 12 million people live in Sao Paulo, and all adult age groups have been opened up to shots in the city; 12-year-olds are the latest age bracket permitted to receive a dose. But many residents – 211,000, Nunes said – have only received the first shot due to long wait times between doses. 

People wait for their COVID-19 test results at a rapid testing tent set up to provide tests for the new health pass at a restaurant plaza in Marseille, southern France, Aug 9, 2021. (DANIEL COLE / AP)

Canada

The Canadian province of British Columbia will require patrons of non-essential businesses such as restaurants and movie theatres to be vaccinated against COVID-19 from Sept 13, the government said on Monday.

The vaccine requirement will also cover fitness studios along with sporting events, concerts, weddings and other private and public indoor social events, health officials said.

British Columbia, Canada's westernmost province, is reporting some of the country's highest rates of new COVID-19 cases per capita and recently mandated vaccines for staff of long-term care homes. The province reported 663 new cases on Friday, the most recent data available. read more

People wanting to enter a non-essential business must have at least one dose of vaccine starting Sept 13 and both doses by Oct 24, Premier John Horgan said.

Currently, 73 percent of Canadians aged 12 and over are fully vaccinated, according to government data. 

The majority of Canadians are in favour of widespread vaccine mandates, a poll by Nanos Research in early August found, with 74 percent supporting or somewhat supporting such a measure.

France

France's Haute Autorite de Sante (HAS) health watchdog said on Tuesday it recommended a COVID-19 vaccine booster shot for those aged 65 and over and for those with existing medical conditions that could put at them serious harm from COVID.

These COVID-19 vaccine booster shots should be rolled out from the end of October onwards, it added.

In this file photo taken on Aug 03, 2021, a mother and her 12-years-old twin girls watch an information video prior to the vaccination of the young girls with the BioNTech vaccine at the district vaccination center in Ludwigsburg, southern Germany, amid the ongoing COVID-19 pandemic. (THOMAS KIENZLE / AFP)

Germany

Germany has decided to stop using the coronavirus infection rate as its yardstick for deciding if restrictions should be in force to contain the spread of the virus, Chancellor Angela Merkel said on Monday.

The seven-day incidence rate was a key measure in determining whether restrictions could be imposed or lifted, with infection thresholds of 35, 50 and 100 per 100,000 people triggering the opening or closure of different parts of society.

But as the number of people who are fully vaccinated rises, calls have grown for the incidence rate to be dropped as a measure to determine whether lockdowns are necessary.

"We decided today that we no longer need comprehensive protective measures when the number of cases or incidence is 50, because a large proportion of the people are vaccinated," Merkel said.

The government and federal states will instead monitor hospitalizations as a key indicator for whether the health system is becoming overburdened, Merkel said.

Merkel added Berlin would discuss how to define the new measure in talks in the coming weeks with the 16 state premiers, who are in charge of health policies.

Germany reported 3,668 new coronavirus infections on Monday and a seven-day incidence rate of 56.4, according to the Robert Koch Institute for infectious diseases.

Some 59 percent of the population are full-vaccinated with around 64 percent having received at least one dose.

Global tally

Coronavirus cases worldwide surpassed 212.51 million while the global death toll topped 4.44 million, according to data compiled by Johns Hopkins University.

Greece

Greece said it would end free testing for unvaccinated people to boost inoculation rates and head off any renewed spike in Delta variant infections of the coronavirus.

The country has recorded 13,422 deaths since reporting its first COVID-19 outbreak in February 2020.

New measures which will come into effect on Sept 13 stop short of forcing people to take a jab, but end free testing and oblige unvaccinated persons to test either once or twice a week, depending on their profession.

The costs of the rapid test, set at 10 euros (US$12), is a sizeable chunk of money for people in the crisis-hit country where salaries average 1,161 euros a month.

Meanwhile, Greece's top medical advisers said on Monday vulnerable groups with underlying diseases should get COVID-19 vaccine booster shots, in a bid to curb a rise in Delta variant infections.

The booster shot with mRNA vaccines, if approved by the government, will be available in the first week of September, the head of the National Vaccination Committee told reporters.

"It will be given four weeks after the second dose in high-risk groups," Maria Theodoridou said.

People who had undergone transplants or suffered from kidney failure, cancer patients and individuals with compromised immune systems were among the vulnerable groups, Theodoridou said.

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Medical workers remove the body of a coronavirus patient who had died, past others as they lie on their beds, in the intensive care unit of a hospital in Machakos, Kenya on Aug 20, 2021.  (BRIAN INGANGA / AP)

Kenya

Kenya's travel and hospitality industry has witnessed gradual recovery as the country intensifies vaccination against COVID-19 while wooing visitors from non-traditional source markets, officials said Monday.

Joseph Boinnet, chief administrative secretary in the Ministry of Tourism and Wildlife, said the government has prioritized enhanced virus mitigation measures and diversification to boost tourist arrivals into the country.

"The resilience of the travel and tourism industry has been strengthened by robust measures that have been put in place to curb further spread of coronavirus," Boinnet said during the virtual launch of a report on outlook on recovery for the travel industry in Kenya.

He said proactive measures undertaken by the government including reopening public and privately managed wildlife sanctuaries have facilitated recovery of the hospitality sector.

Malta 

Malta is set to further relax measures while curbing the spread of coronavirus by allowing fully vaccinated people to attend standing events such as concerts and festivals from Sept 6, Health Minister Chris Fearne announced on Tuesday.

Fearne said the number of attendees would initially be limited to 100 people. 

The health minister also said that a third booster vaccine dose will be given to immunosuppressed people, and elderly people living in care homes. The rollout process is expected to start on Sept 13.

Morocco

Morocco reported on Monday 2,996 new COVID-19 cases, bringing the total infections in the country to 813,945.

The death toll rose to 11,889 with 97 new fatalities during the last 24 hours, while 2,582 people are in intensive care units, according to a statement by the Ministry of Health.

Nigeria

Nigeria has approved the Sinopharm vaccine against COVID-19 in the past three days, the head of the country's primary healthcare agency said.

Nigeria has been allocated 7.7 million doses of the vaccine through the COVAX scheme aimed at providing vaccines to developing countries, although it has not yet received the doses.

The number of people testing positive for coronavirus has risen sharply in Lagos, Nigeria’s commercial hub and Africa’s biggest city. 

The test positivity rate jumped to 12.1 percent as of Aug 21 from 7 percent at the end of July, Babajide Sanwo-Olu, the governor of the state said in an emailed statement. 

The state has also recorded a total of 135 deaths since the third wave of infections started at the end of June when the test positivity rate was 1.1 percent, Sanwo-Olu said. 

“We are now clearly in the middle of third wave of the COVID-19 pandemic and Lagos has remained the epicenter of the disease in Nigeria,” he said. 

A total of 4,387 persons are currently being treated for the illness in the state. The number of oxygen cylinders used has also shot up to 400 daily when compared to just 75 cylinders before the current wave. 

The state plans to start a new vaccination round from Aug 25 with 300,000 doses of Moderna vaccines it received from the federal government. 

Russia

Russia reported 18,833 new coronavirus cases on Tuesday, including 1,105 in Moscow, which took the national tally to 6,785,374.

The Russian coronavirus task force said 794 more deaths of coronavirus patients had been confirmed in the past 24 hours, bringing the official death toll to 177,614.

A medical worker injects a second dose of AstraZeneca vaccine to a patient in a coronavirus vaccination centre in Kigali, Rwanda on May 27, 2021. (LUDOVIC MARIN / AFP)

Rwanda

Rwanda on Monday started the third phase of mass COVID-19 vaccinations targeting adults 18 years and above in Kigali, the national capital, the Ministry of Health said.

Health personnel expect to account for more than 90 percent of the eligible group over a two-week vaccination exercise at multiple vaccination sites across the Kigali districts of Gasabo, Kicukiro and Nyarugenge, Tharcisse Mpunga, the Rwandan state minister in charge of Primary Healthcare, told Xinhua by phone.

Expanding eligibility to people 18 years and older aims to reach workers of different sectors of the economy who are the majority and it is expected to help the country return to normal business, the minister said, adding that mobile teams were also moving from door to door to vaccinate elderly people and those with mobility challenges.

In a statement issued earlier Sunday, the ministry explained that the vaccination campaign was to start with Kigali as it's the densely populated zone in the country with the highest infection rate.

Scotland

Scottish First Minister Nicola Sturgeon said her government could reimpose coronavirus restrictions amid a record number of new daily cases.

The country of 5.5 million people reported 4,323 new COVID-19 cases in the last 24 hours, the highest daily number since the start of the pandemic.

ALSO READ: US FDA grants full approval to Pfizer-BioNTech's vaccine

“If this surge continues and accelerates and we start to see evidence of substantial increase in serious illness, we cannot completely rule out having to reimpose some restrictions,” Sturgeon told reporters in Edinburgh.

The bulk of Scotland’s remaining restrictions on movement and social interaction were lifted in early August as increasing numbers of the country’s population received their vaccinations.

UK

Another 31,914 people in Britain have tested positive for COVID-19, bringing the total number of coronavirus cases in the country to 6,524,581, according to official figures released Monday.

The country also reported another 40 coronavirus-related deaths. The total number of coronavirus-related deaths in Britain now stands at 131,680.

Medics transfer a patient on a stretcher from an ambulance outside of Emergency at Coral Gables Hospital where Coronavirus patients are treated in Coral Gables near Miami, on Aug 16, 2021. (CHANDAN KHANNA / AFP)

United States

Hawaii Governor David Ige urged residents and visitors to restrict travel to the US state to essential business activities amid a surge in cases of COVID-19 in the islands.

The governor highlighted the restrictions on restaurant capacities and limited access to rental cars and said that those who choose to visit the islands will not be able to enjoy a typical Hawaii holiday.

"It is not a good time to travel to the islands," the governor said in a press conference on Monday.

"We are seeing more COVID patients in our hospitals and ICUs are filling up," he said, adding that the state is working towards expanding healthcare facilities.

The governor said that he supported Honolulu Mayor Rick Blangiardi's announcement on restricting indoor gatherings to 10 people and outdoor gathering to 25.

Separately, US COVID-19 new cases, hospitalizations, deaths continue to climb due to the spread of the highly contagious Delta variant, showed data from the Centers for Disease Control and Prevention (CDC).

The current 7-day moving average of daily new cases (133,056) increased 14.0 percent compared with the previous 7-day moving average (116,740), according to the latest CDC weekly report.

As to the new hospital admissions, the current 7-day average for Aug 11-Aug 17 was 11,521, a 14.2 percent increase from the prior 7-day average (10,088) from Aug 4- Aug 10, said the report.

The current 7-day moving average of new deaths (641) has increased 10.8 percent compared with the previous 7-day moving average (578).

Nationally, the combined proportion of cases attributed to Delta is estimated to increase to 98.8 percent, said the report.