Published: 10:36, December 1, 2020 | Updated: 09:38, June 5, 2023
Moderna, Pfizer-BioNTech seek EU approval for vaccines
By Agencies

A bus stop ad for COVID-19 testing is shown outside Pfizer world headquarters in New York on Nov 9, 2020. (PHOTO / AP)

ZAGREB / MEXICO CITY / GENEVA / LONDON / ALGIERS / ROME / SAO PAULO / PARIS / BOGOTA / NEW YORK / BELGRADE / BERLIN / SOFIA / BUENOS AIRES / UNITED NATIONS / HARARE / SANTIAGO / OTTAWA / ADDIS ABABA / MOSCOW / FRANKFURT / AMSTERDAM / GABORONE - Pfizer Inc and BioNTech have applied to the European drugs regulator for conditional authorization of their COVID-19 vaccine, following similar steps in the United States and Britain, the companies said on Tuesday.

The application to the European Medicines Agency (EMA) comes after the companies applied for US approval on Nov 20, taking them a step closer to launching their vaccine.

Pfizer and BioNTech reported final trial results on Nov 18 that showed their vaccine candidate was 95 percent effective in preventing COVID-19, with no major safety concerns, raising the prospect of US and European approval as early as December.

The European filing completes the so-called rolling review process, which was initiated with the EMA on Oct 6.

Meanwhile, the EMA said on Tuesday it has received an application for marketing authorization for Moderna Inc’s COVID-19 vaccine candidate.

Moderna Inc said on Monday it has applied for US emergency authorization for its COVID-19 vaccine after full results from a late-stage study showed it was 94.1 percent effective with no serious safety concerns.

The US Food and Drug Administration (FDA) said an advisory committee would meet to discuss the request on Dec 17, making Moderna's candidate the second highly effective vaccine likely to receive US regulatory backing and a potential roll out this year.

Earlier, the company had said in a statement it would seek clearance on Monday in both the US and Europe.

Moderna reported that its vaccine's efficacy was consistent across age, race, ethnicity and gender demographics as well as having 100 percent success in preventing severe cases of the disease.

"We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it," Moderna Chief Medical Officer Tal Zaks said. "We expect to be playing a major part in turning around this pandemic."

Children approach a Colombian Air Force blackhawk helicopter bringing school kits and humanitarian aid, at the Acandi village airport in Choco department, Colombia, on Oct 14, 2020. (JOAQUIN SARMIENTO / AFP)

UN

The COVID-19 pandemic has fueled a 40 percent increase in the number of people needing humanitarian assistance around the globe, the United Nations (UN) said on Tuesday, as it appealed for roughly US$35 billion to help many of those expected to be in need next year.

If everyone who will need humanitarian aid next year lived in one country, it would be the world's fifth largest nation.

Mark Lowcock, 

UN aid chief

"If everyone who will need humanitarian aid next year lived in one country, it would be the world's fifth largest nation," UN aid chief Mark Lowcock said.

ALSO READ: UN: Virus could result in more HIV & AIDS-related deaths

The UN has set out 34 humanitarian response plans covering 56 countries for 2021, aiming to help 160 million of what it forecasts to be 235 million most vulnerable people worldwide facing hunger, conflict and the impacts of climate change and the coronavirus pandemic.

Lowcock said this year donors gave a record US$17 billion to fund humanitarian operations and data showed that aid reached 70 percent of the people targeted.

Meanwhile, the UN also said Monday that the pandemic was heightening the dangers of gender-based violence and human trafficking for women and girls.

Lockdowns and other measures implemented during the pandemic have led to a "shadow pandemic" of rising gender-based violence, according to the UN Office on Drugs and Crime (UNODC).

Women's economic inequality also increases their vulnerability to trafficking and sexual violence, according to UN Women.

"Forty-seven million more women and girls will be pushed to extreme poverty because of COVID-19, but business is booming for traffickers," UN Women Executive Director Phumzile Mlambo-Ngcuka said.

WHO

The World Health Organization (WHO) said that governments need to take a risk-management approach to all activities that involve people congregating, including skiing, as winter approaches.

The WHO said nations should take a "risk-based approach", deciding which activities can go ahead and which should be postponed - and if they can't be postponed, how they can be done safely to minimize new infections.

We would ask that all countries look at the ski season and other reasons for mass gatherings and look very, very carefully at the associated risks.

Mike Ryan, Head of WHO’s emergencies program

“The real issues are at airports, on buses to and from ski resorts, ski lifts - pinch points where people come together in large numbers,” said Mike Ryan, head of WHO’s emergencies program.

"We would ask that all countries look at the ski season and other reasons for mass gatherings and look very, very carefully at the associated risks," Ryan said.

The WHO expert also said that the world risked future pandemics if it suffered "amnesia" and did not learn from the current coronavirus crisis.

ALSO READ: WHO: Malaria to kill more than virus in sub-Saharan Africa

Ryan also took a swipe at developed nations, saying that northern countries had been running healthcare systems "like low-cost airlines" and that the world was paying for that now.

WHO Director-General Tedros Adhanom Ghebreyesus also urged countries not to politicize the hunt for the origins of the new coronavirus, saying that would only create barriers to learning the truth.

The WHO is doing everything it can to find the origin of the coronavirus, despite attempts by some to politicize the process, Tedros said.

Global tally

Coronavirus cases worldwide has surpassed 63.2 million while the global death toll topped 1.46 million, according to data compiled by Johns Hopkins University.

Africa tally

The number of confirmed COVID-19 cases on the African continent has reached 2,170,843, the Africa Centers for Disease Control and Prevention (Africa CDC) said on Tuesday.

The continental disease control and prevention agency said in a statement that the death toll related to the pandemic stood at 51,915 as of Tuesday afternoon, while 1,840,575 people infected with COVID-19 have recovered.

Algeria

Algerian President Abdelmadjid Tebboune has left a German hospital where he was flown for treatment more than a month ago, and he will return home "in the coming days," the presidency said on Monday.

Tebboune, 75, who has tested positive for COVID-19, will continue "the rest of the recovery period" in Germany, it said in a statement.

Argentina

The Argentine Ministry of Health on Monday reported 5,726 new COVID-19 cases over the past 24 hours, taking the national count to 1,424,533.

The ministry said 257 newly reported deaths took the toll to 38,730.

The province of Buenos Aires, with 618,726 cases, is the most affected city in the country.

Daily infections continued to decline steadily in Argentina, but the pandemic still presents a threat to public health, the ministry warned.

"The pandemic is not over, and we are still working to be able to continue opening up, to continue the recovery of different activities," Secretary of Health Access Carla Vizzotti said.

Belgium

Belgium’s 7-day average test positivity rate for the coronavirus dropped to less than 10 percent for the first time since the period ended Oct 7. 

It was as high as 29 percent at the peak of the current outbreak in October. Virologists want to see the ratio of positive tests fall to less than 3 percent before easing restrictions.

Botswana

Botswana's health authorities on Monday warned the public to avoid non-essential travel during the upcoming Christmas holiday season due to the COVID-19 pandemic.

In a communique, the Presidential Task Force for COVID-19 called on the public to take responsibility by avoiding visits to the elderly who are at a high risk of developing severe symptoms of COVID-19.

People who take private cars to visit their loved ones should consider a two-week self-isolation before departure, while those using public transport should quarantine themselves for two weeks upon arrival, according to the communique. The public was further advised to avoid visiting other households to prevent possible virus transmission.

The warning came a day before the country reopened its borders.

Botswana has registered 9,252 local cases and 1,490 cases at its borders so far, Mosepele Mosepele, the deputy coordinator of the Presidential Task Force for COVID-19, said. The country's COVID-19 death toll stood at 34, said Mosepele.

Brazil

The state of Sao Paulo, home to Brazil's biggest city, imposed stricter social distancing measures on Monday as it wrestles to contain a fresh rise in COVID-19 cases.

Opening hours and capacities for bars, restaurants and shopping malls will be restricted in Brazil's most populous state, Governor Joao Doria said, adding that the restrictions would not impact the reopening of schools.

On Monday, 21,138 new infections and 287 more deaths were reported, raising the tally to 6,335,878 and the toll to 173,120, the Health Ministry said.

The WHO urged Brazil to be "very, very serious" about its rising coronavirus infection numbers, which the WHO chief described as "very, very worrisome".

Bulgaria

Bulgaria's COVID-19 death toll has risen to 4,035 after a record high of 221 new deaths were reported in the last 24 hours, the health ministry said Tuesday.

According to the ministry, the number of confirmed infections has reached 145,300, up 2,814 over the past 24 hours.

With coronavirus death rates surging to record levels in Bulgaria, doctors and nurses in a health service already weakened by decades of emigration to the West say they are exhausted.

A surge in infections has overwhelmed hospitals in the European Union's poorest country this autumn, with patients increasing almost threefold in November to 6,869.

Bulgaria has recorded almost 4,000 new cases daily so far this month. On Monday, it had the EU's highest cumulative per capita death rate of 24.1 per 100,000 over the past two weeks.

The country's healthcare system, under-funded and short of staff, has seen 5,800 medics infected on the job, with 2,000 positive at present, out of a total of 52,000. About 60 percent of Bulgaria's doctors and nurses are over 51 years old, making them more vulnerable to the virus.

Canada

The Canadian government unveiled a new financial program worth billions of Canadian dollars Monday afternoon to boost the Canadian economy amid the COVID-19 pandemic.

The government's immediate priority is to do whatever it takes to help Canadians and businesses stay safe and solvent amid the pandemic challenge, Canadian Deputy Prime Minister and Finance Minister Chrystia Freeland said at the Canadian House of Commons Monday afternoon.

As of Monday afternoon, Canada has reported a total of 374,051 COVID-19 cases and 12,076 deaths, according to CTV.

The country is on track to have 4,000 COVID-19 patients in hospitals by Christmas, a figure that would eclipse the peak of the first wave and put tremendous pressure on a healthcare system already pushed to the brink by nine months of fight against the pandemic.

Chile

Chile's Health Minister Enrique Paris on Monday presented an emergency plan in case the country is hit by a second wave of COVID-19.

"We are prepared, we have ventilators and equipment. But the (healthcare) staff must be supported with replacements, because they are exhausted," Paris said at a press conference.

The presentation came as the Health Ministry reported 1,313 new COVID-19 cases and 54 more deaths, taking the tally to 551,743 and the death toll to 15,410.

Colombia

Colombia will keep its land and river borders closed until Jan 16, its migration agency said on Monday, in an effort to contain the spread of coronavirus despite illegal crossings.

Sea borders, also closed since March, will open from Tuesday, agency director Juan Francisco Espinosa in a statement, adding the agency is looking into how to safely reopen land and river borders with neighboring countries' governments.

Colombia reported 8,430 new COVID-19 cases in the past 24 hours, bringing the tally to 1,316,806, health authorities said Monday.

The death toll rose by 182 to 36,766, the authorities said.

Croatia

Croatia's Prime Minister Andrej Plenkovic has tested positive for the coronavirus, the government's spokesman said on Monday.

Plenkovic has already been at home in isolation because his wife tested positive for COVID-19 over the weekend. Plenkovic's test over the weekend was negative.

"Prime Minister Plenkovic will remain at home in isolation for 10 days. He feels well and he will continue with his duties from his home following all the recommendations of doctors and epidemiologists," the spokesman said. 

Croatia reported 1,830 new COVID-19 cases and a record 74 deaths on Monday, the Croatian Institute of Public Health said. The figures took the tally past 120,000 and the toll to 1,786.

The capital Zagreb rolled out on Monday free antigen tests for COVID-19 in schools, with an aim of testing 3,000 students and teachers.

Denmark

Denmark is planning to unveil tougher restrictions for the greater Copenhagen area. Health Minister Magnus Heunicke will announce the measures later on Tuesday after infection rates “have become too high” in the capital, he said in a Facebook post.

EU

Vaccinations may be available to European Union citizens before the end of this month, after the European Commission recently secured about 2 billion doses, President Ursula von der Leyen said during a parliamentary forum.

France

France's recorded 4,005 new COVID-19 infections on Monday, the smallest rise since August.

The seven-day moving average of daily new infections, which smoothes data-reporting irregularities, stood at 11,118, an almost two-month low.

The cumulative number of cases now totals more than 2.2 million, the fifth-highest tally in the world. 

The number of patients in intensive care units only fell by five to 3,751, and hospitalizations declined by 55 to 28,258.

The death toll rose by 406 to 52,731, the seventh-highest in the world, versus 198 on Sunday. 

Germany

German Health Minister Jens Spahn said he expects the first wave of high-risk groups to begin receiving COVID-19 vaccinations in January. 

The country is preparing special vaccination centers for mid-December, he said in an interview with DLF radio. Germany aims to have doctors administering vaccines in their offices from the spring or early summer, Spahn said.

Coronavirus cases in Germany increased by 13,604 to 1,067,473 while deaths rose by 388 to 16,636, data from the Robert Koch Institute (RKI) for infectious diseases showed on Tuesday.

Chancellor Angela Merkel said on Monday that Germany could face a third wave of coronavirus infections if citizens are careless in the coming weeks.

"We'll have to be very, very careful during the winter," Merkel said in a virtual panel discussion with police officers. "Otherwise we'll end up directly in the next wave."

Merkel also railed against plans of some regional governments to let hotels open for family visits over Christmas, warning it risked worsening the coronavirus surge sweeping Germany, participants in a party meeting said.

Italy

Italy reported 672 COVID-19-related deaths on Monday, against 541 on Sunday, and 16,377 new infections, down from 20,648 the day before, the health ministry said.

The country has recorded 55,576 COVID-19 fatalities and 1.6 million cases in total. 

The number of people in hospital with COVID-19 stood at 33,187 on Monday, up 308 on the day before.

The number in intensive care decreased by nine, the same decline as was seen on Sunday, and now stands at 3,744.


A health worker looks after a patient at a military hospital set up for COVID-19 treatment in Mexico City, Nov 30, 2020. (MARCO UGARTE / AP)

Mexico

The WHO chief said Monday that Mexico is in "bad shape" regarding the coronavirus as infections and deaths surge, while the Mexican government forecast the pandemic would likely continue worsening until January.

Mexico's health ministry reported 6,472 newly confirmed cases of coronavirus infection and 285 additional fatalities Monday, bringing the total in the country to 1,113,543 cases and 105,940 deaths.

The number of increase in cases and deaths in Mexico is very worrisome. When both indicators ... increase I think this is a very serious problem and we would like to ask Mexico to be very serious.

Tedros Adhanom Ghebreyesus, WHO director-general

"The number of increase in cases and deaths in Mexico is very worrisome," WHO's Director-General Tedros Adhanom Ghebreyesus said. Citing the increase in the number of weekly deaths from 2,000 the week of Oct 12 to around 4,000 by Nov 23, "This shows Mexico is in bad shape," he said.

"When both indicators, deaths and cases, increase I think this is a very serious problem and we would like to ask Mexico to be very serious," said Tedros.

At least seven of Mexico City's 54 public hospitals treating COVID-19 patients are at full occupancy for coronavirus beds with respirators, according to a report by the United Nations Office for the Coordination of Humanitarian Affairs (OCHA).

The OCHA said another 14 health centers risk being stretched, with COVID-19 bed occupancies exceeding 70 percent. It noted that Mexico's Health Ministry reported 63 percent of all general hospital beds for COVID-19 patients in the capital are occupied.

Speaking later at an evening news conference, Mexico's Deputy Health Minister Hugo Lopez-Gatell said said the pandemic would very probably continue to worsen in Mexico until January.

READ MORE: Moderna plans to seek US, EU clearance for COVID-19 vaccine

Netherlands

A law mandating the use of face masks to slow the spread of coronavirus went into effect in the Netherlands on Tuesday, completing a gradual turnabout in policy.

With the country in a "partial lockdown" since Oct 13, health authorities are expected to release weekly figures later on Tuesday that will show new COVID-19 infections are about flat from the 36,931 cases reported for the week ended Nov 24.

A requirement that masks be worn in public buildings, including schools, supermarkets and restaurants, will be imposed for an initial three months. Violators can be fined up to 95 euros (US$114).

Novavax

Novavax Inc on Monday pushed back the start of a US-based, late-stage trial for its experimental COVID-19 vaccine for the second time and now expects it to begin in the coming weeks instead of November.

While the US trial has been hampered by issues in scaling up the vaccine's manufacturing, Novavax has a late-stage study underway in the UK which finished enrollment on Monday.

The company plans to use vaccine material produced at commercial scale for the trial in the United States and Mexico and has been working closely with the US FDA to allow the use of the vaccine made at a North Carolina plant.

Novavax is also running a fully enrolled Phase 2b trial in South Africa with over 4,400 volunteers, including 245 who are medically stable, HIV positive participants. Efficacy data from that trial could also be available in the first quarter of next year.

Volunteers wait to be checked at a vaccine trial facility at Soweto's Chris Sani Baragwanath Hospital, outside Johannesburg, South Africa, Nov 30, 2020. (JEROME DELAY / AP)

Russia

Russia reported a record 569 deaths linked to the novel coronavirus on Tuesday, bringing the official death toll to 40,464.

Authorities also reported 26,402 new coronavirus infections in the last 24 hours, including 6,524 in the capital Moscow, bringing the national cumulative tally to 2,322,056.

Serbia

Serbia plans to start laboratory testing of Russia's Sputnik V vaccine against the coronavirus and it will also continue talks with drugmaker Pfizer Inc about purchasing its shot, the country's prime minister said on Monday.

Russia will deliver 20 doses of its vaccine to Serbia for laboratory testing by the end of the week, the office of Prime Minister Ana Brnabic said in a statement after speaking via videoconference with Russia's trade and industry minister Denis Manturov.

"Serbia is interested in ... a possibility of a joint production of the vaccine," reads the statement.

Brnabic will continue talks with Pfizer on Tuesday, according to the statement. No further details were mentioned in the statement.

So far, 175,438 people have fallen ill with COVID-19 in Serbia, which has a population of 7.2 million, and 1,604 have died from it.

UK

Senior British minister Michael Gove said that the government was not planning a system of vaccine passports which would prevent those who hadn't had a COVID-19 jab from going to the pub or attending events.

His remarks came a day after newly appointed vaccine minster Nadhim Zahawi said on the same day that people who refuse a vaccine for COVID-19 could find normal life curtailed as restaurants, bars, cinemas and sports venues could block entry to those who don't have proof they are inoculated.

Meanwhile, earlier on Tuesday, the government said a type of COVID-19 test that can be taken without the need for a nose or throat swab has been found to be highly effective in identifying infectious cases, including for people not showing symptoms.

The health ministry said the RT-LAMP tests were found to have a sensitivity of 79 percent and specificity of 100 percent, meaning they were effective in identifying the people who were infectious and most likely to transmit the disease.

The United Kingdom reported 12,330 new cases of COVID-19 on Monday, taking the tally to 1,629,657 cases, government data showed. Another 205 deaths lifted the death toll to 58,448.

The virus reproduction number, known as the R number, has fallen to between 0.9 and 1, according to the latest official figures

Prime Minister Boris Johnson said Monday he hoped the leading COVID-19 vaccine candidates would be approved by regulators before Christmas.

US

US Vice-President Mike Pence told governors on Monday that distribution of a coronavirus vaccine could begin by the third week of December, signaling that US regulators will swiftly approve an emergency authorization for the first shots.

“We strongly believe the vaccine distribution process could begin the week of December 14,” Pence told governors, according to a summary of the call provided by the office of Washington Governor Jay Inslee. 

US Health Secretary Alex Azar said Pfizer's medication could be authorized and shipped within days of a Dec 10 meeting of outside advisers to the Food and Drug Administration. Moderna's vaccine could follow a week later, Azar said

US Health Secretary Alex Azar said Pfizer's medication could be authorized and shipped within days of a Dec 10 meeting of outside advisers to the Food and Drug Administration. Moderna's vaccine could follow a week later, Azar said.

The US Centers for Disease Control and Prevention (CDC) on Monday reported 13,295,605 cases of the new coronavirus, an increase of 152,608 from its previous count, and said that the number of deaths had risen by 885 to 266,051.

Hospitalizations reached an all-time high of 93,238 on Sunday, according to the latest data of the COVID Tracking Project.

California is considering a return to stay-at-home orders as hospitalizations soar, with projections showing that intensive-care demand will exceed capacity in the next month. Governor Gavin Newsom warned that hospitalizations are expected to double or triple by Christmas.

Meanwhile, White House coronavirus adviser Scott Atlas, who won President Donald Trump’s favor by advocating the loosening of social distancing restrictions during the pandemic, resigned his post on Monday, according to a White House official.

Federal Reserve Chairman Jerome Powell warned that the rise in COVID-19 cases, both at home and abroad, could pose challenges to the economic recovery in the next few months.

Separately, scientists at the US CDC found evidence of COVID-19 infection in blood donations collected by the American Red Cross from residents in nine US states between Dec 13, 2019, and Jan 17, 2020, according to a study published online in the journal Clinical Infectious Diseases.

Zimbabwe

Zimbabwe reported 84 new COVID-19 cases on Monday, bringing the national tally to 10,034, said the Ministry of Health and Child Care.

The country has recorded 8,489 recoveries and 277 deaths since the onset of the pandemic in March, said the ministry, adding that the number of locally transmitted infections has increased in recent weeks.

According to a statment issued Monday by Constantino Chiwenga, the country's vice-president and minister of health and child care, Zimbabwe will reopen its borders on Tuesday.

People entering Zimbabwe and who are not citizens or returning residents must "exhibit a COVID-19-free certificate issued not earlier than the previous 48 hours and not present with symptoms of COVID-19," according to the statement.