Published: 11:17, December 15, 2020 | Updated: 08:11, June 5, 2023
Moderna virus shot found safe, effective before key FDA review
By Agencies

Sandra Lindsay (left), a nurse at Long Island Jewish Medical Center, is inoculated with the Pfizer-BioNTech COVID-19 vaccine in the Queens borough of New York on Dec 14, 2020. Lindsay was the first person in the United States to receive a COVID-19 vaccine. (MARK LENNIHAN / POOL / AP)

GENEVA / TORONTO / MOSCOW / LONDON / NEW YORK / SANTIAGO / CAPE TOWN / CAIRO / DAKAR / KIEV / STOCKHOLM / TALLINN / MINSK - Moderna Inc’s vaccine is safe and effective for preventing COVID-19, US regulators said Tuesda, clearing the way for a second shot to quickly gain emergency authorization and add to the country’s sprawling immunization effort.

The Food and Drug Administration’s staff said in a report that the experimental vaccine is 94.1 percent effective at preventing symptomatic COVID-19, confirming earlier results released by the company.

The report was posted online ahead of a meeting Thursday of agency advisers who will vote whether to recommend authorization before a final FDA decision. 

The US reached the grim milestone of 300,000 coronavirus deaths on Monday, according to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University.

With the national case count topping 16.3 million, the death toll across the United States rose to 300,267 as of 3:26 pm local time (2026 GMT), according to the CSSE data.

A New York City intensive care unit nurse on Monday became the first person in the country to receive a coronavirus vaccine, saying she felt “healing is coming,” as the nation began inoculations.

Acting Defense Secretary Chris Miller also got his on Monday at Walter Reed National Military Medical Center outside Washington, apparently the first Cabinet-level official inoculated.

New York is moving toward a second full shutdown if COVID-19 cases and hospitalizations continue at their current pace, Governor Andrew Cuomo said.

“If we do not change the trajectory, we could very well be headed to shut down” all non-essential businesses, Cuomo said Monday at a virus briefing.

In this Dec 9, 2020, file photo, a test specialist works at a COVID-19 testing site in Los Angeles.  (PHOTO / AP)

Meanwhile, the US Department of Agriculture said that it has confirmed the first known case of the coronavirus in a wild animal, a mink.

The discovery increases concerns about outbreaks in mink as the virus has killed more than 15,000 farmed mink in the United States since August.

Separately, Democratic US House of Representatives Speaker Nancy Pelosi and Treasury Secretary Steven Mnuchin discussed a massive government spending bill meant to avert a government shutdown and a fresh round of COVID-19 relief on Monday, a Pelosi spokesman said.

Pelosi reiterated Democratic concerns about liability provisions in the COVID-19 relief bill, and told Mnuchin that remaining unresolved items in the spending bill could be resolved easily, Pelosi spokesman Drew Hammill wrote on Twitter.

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

South Africa

South Africa’s government will curb alcohol sales and close some beaches at the height of the summer-holiday season as part of a series of new restrictions in response to surging infections. 

The number of daily new cases doubled this month. The country is fast-approaching 1 million infections, with 866,127 people having contracted the disease so far, President Cyril Ramaphosa said on Monday.

South Africa on Monday reported 5,163 new coronavirus cases over the past 24 hours, bringing the national tally to 866,127, the country's health department reported.

Another 175 COVID-19 deaths were recorded, taking the death toll to 23,451, it said.

The ministry also reported a total of 762,746 recoveries from the disease to date.

Amid the pandemic, South Africa has been hit by a shortage of mental health medication and contraceptives as the outbreak and the associated lockdown disrupted manufacturing and imports.

The number of so-called stock-outs, when a medicine is unavailable, has doubled this year to over 1,400 reports, according to Ruth Dube, project coordinator at the Stop Stockouts Project, a non-profit that campaigns to end medicine scarcity. Medicines that have run short include lithium, used to treat bipolar disorder, as well as the injectable contraceptives Depo-Provera and Nur-Isterate, made by Aspen Pharmacare and Bayer AG respectively, according to Dube.

The Gauteng Department of Health, which oversees health matters in South Africa’s most populous province, said the scarcity is due to a shortage of ingredients needed to make the medicines. Demand also rose during the lockdown, while local manufacturers had their operations interrupted, the department said in an October statement.

ALSO READ: Beware of holidays, says WHO chief

EU

Pressure is building in Europe for quick approval of Pfizer Inc and BioNTech SE’s COVID-19 vaccine, with German authorities saying they’re optimistic that sign-off can be pushed forward by a week amid a rising death toll on the continent.

Germany is “optimistic” that the European Medicines Agency (EMA) will be able to make a decision by Dec 23, Health Minister Jens Spahn said in Berlin on Tuesday. The EMA had previously said an advisory board would convene by Dec 29 to make a recommendation on the application; approval would come within days after that.

The EMA is working “around the clock” on the vaccine and may make a decision before Dec 29, Executive Directer Emer Cooke told Germany’s Handelsblatt newspaper. Still, that remains the date planned for clearance, German magazine Focus cited an EMA spokeswoman as saying. The agency’s press office didn’t immediately return requests for comment on Tuesday.

The European process also means shipping doses throughout the EU, where countries are making their own plans for distribution. In Germany, vaccination centers were told to be ready by Tuesday. In Italy, where the government is still finishing its deployment plan, Health Minister Roberto Speranza said he hoped the vaccine would get a sign-off ahead of schedule.

Belarus

Belarus reported 1,911 new COVID-19 cases on Tuesday, taking its tally to 164,059, the country's health ministry reported.

The number of recoveries rose by 1,658 to 141,443, the ministry added.

The death toll climbed by nine to 1,282, it said.

Estonia

Estonia's Health Board on Tuesday reported 301 new COVID-19 cases within the last 24 hours, bringing its total caseload to 18,682.

As of Tuesday morning, 157 people have died of COVID-19 in Estonia after three more deaths were registered, it said.

Senegal

Mamadou Ndiaye, the director of Prevention of Senegalese Ministry of Health and Social Action, announced on Tuesday that the first doses of a COVID-19 vaccine will be available in Senegal from March 2021.

Ndiaye said during an interview with radio Sud FM that members of Gavi - the Vaccine Alliance - including Senegal would have these first doses after approval by the World Health Organization (WHO).

Senegal has so far recorded 17,216 confirmed cases of COVID-19, including 350 deaths and 16,243 recoveries. 

Georgia

Georgia reported 3,837 new COVID-19 cases on Tuesday, bringing its tally to 194,900, the National Center for Disease Control and Public Health said.

Of the new cases, 1,461 were reported in the capital city of Tbilisi, the center said.

As of Tuesday, 164,786 patients have recovered while the death toll stood at 1,883, said the center.

Ukraine

Ukrainian Cabinet of Ministers has approved a list of quarantine restrictions to take effect on Saturday, the government's press service said on its official website Monday.

The new restrictions include a ban on holding mass celebrations in educational and entertainment establishments, as well as in cafes and restaurants. Museums, exhibition halls and galleries can receive visitors for no more than one person per 10 square meters.

In addition, restaurants, cafes, and bars will be required to close at 11 pm (0900 GMT) except for deliveries and takeaways, and on New Year's night, they will be allowed to operate until 1 am (2300 GMT).

A total of 909,082 COVID-19 cases and 15,480 deaths have been registered in Ukraine as of Tuesday, while 522,868 patients have recovered, the country's health ministry reported.  

WHO

A senior World Health Organization (WHO) official said on Tuesday that the body was looking at new financial instruments to help fill a US$28 billion finance gap for COVID-19 tools, saying financing was proving a “real challenge”.

“Its a real challenge in today’s fiscal environment despite the fact that this is the best deal in town,” WHO senior adviser Bruce Aylward told Geneva-based journalists. “This will pay itself off in 36 hours once we get trade and travel moving again.”

Meanwhile, Aylward also said that the WHO was in talks with Pfizer to include its COVID-19 vaccine as part of an early global roll out.

Aylward said that he saw a “strong commitment” on the part of its CEO Albert Bourla to set prices at levels appropriate to poorer populations. 

Global tally

Global COVID-19 cases surpassed 72.7 million on Sundan while the related deaths neared 1.62 million, according to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University.

Moderna 

Moderna Inc said on Monday it was informed by the European Medicines Agency (EMA) certain documents related to pre-submission talks of its COVID-19 vaccine candidate were unlawfully accessed in a cyberattack on the medicines regulator.

The EMA, which assesses medicines and vaccines for the European Union, said earlier this month that it had been targeted in a cyberattack, which also gave hackers access to documents related to the development of the Pfizer Inc and BioNTech COVID-19 vaccine.

Moderna said its submission to the EMA did not include any information identifying individual study participants and there is no information at present that any participants had been identified in any way.

READ MORE: WHO: Water crisis in health centers worldwide ups virus risk

UK

Two leading UK's medical journals joined forces to demand Prime Minister Boris Johnson scrap his plan to let households mix over Christmas, in a plea to protect the National Health Service from being overwhelmed.

In a rare joint editorial Tuesday, the British Medical Journal and the Health Service Journal said the government’s relaxation of social distancing rules for five days over the holiday period will increase coronavirus infections and risk putting further strain on hospitals.

Separately, the opposition Labour Party said that Johnson should review his plan to relax coronavirus regulations over the Christmas period.

The appeals came a day after the government announced that due to a surge in cases London would be moving up into England's highest tier of COVID-19 restrictions.

Meanwhile, British scientists said Tuesday they are trying to establish whether the rapid spread in southern England of a new variant of the virus that causes COVID-19 is linked to key mutations they have detected in the strain.

The mutations include changes to the important “spike” protein that the SARS-CoV-2 coronavirus uses to infect human cells, a group of scientists tracking the genetics of the virus said, but it is not yet clear whether these are making it more infectious.

The WHO said Monday it was aware of a new variant of COVID-19 that has emerged in Britain, but there is no evidence the strain behaves differently to existing types of the virus.

“We are aware of this genetic variant reported in 1,000 individuals in England,” the WHO’s top emergencies expert Mike Ryan said a news briefing in Geneva. “Authorities are looking at its significance. We have seen many variants, this virus evolves and changes over time.”

Another 20,263 people in Britain have tested positive for COVID-19, bringing the total number of coronavirus cases in the country to 1,869,666, according to official figures released Monday.

The coronavirus-related deaths in Britain rose by 232 to 64,402, the data showed.

The total number of deaths linked to the virus fell in England and Wales for the first time since September in the week ended Dec 4, according to the Office for National Statistics. A total of 2,835 fatalities mentioned coronavirus on the death certificate, accounting for 23 percent of all deaths. That’s down from 3,040 in the previous week.

Italy

Italian Prime Minister Giuseppe Conte said he plans further curbs to slow the pandemic during the festive season.

“Some further restrictive measures are now necessary,” the premier told newspaper La Stampa. “We have to avoid a third wave at all costs, because the loss of lives would be devastating.”

Conte didn’t specify the measures under consideration, but his ministers are divided over the extent of restrictions during the Christmas and New Year period. Options include closing bars and restaurants, as well as non-essential shops, and strict limits on people leaving their homes.

Italy, the first Western country hit by the pandemic, on Saturday passed Britain as the European nation with the worst official death toll, with more than 65,000 dying since the start of the outbreak in February.

Italy's Ministry of Health reported 491 coronavirus-related deaths on Monday, up from 484 on Sunday. Overall, the country has registered 65,011 fatalities since the start of the pandemic.

The ministry also reported 12,030 new coronavirus cases on Monday (down from 17,938 on Sunday), pushing the total number of confirmed infections to 675,109 in this country of about 60 million people.

Russia 

Russia is close to completing clinical trials for a COVID-19 vaccine for domestic animals and mink and expects to begin the regulatory approval process in February, according to Russia’s agricultural safety watchdog.

The Federal Centre for Animal Health began developing the vaccine in spring after the authorities established the virus could be passed from humans onto some domestic animals.

Russia became the first country to give regulatory approval to a human vaccine - Sputnik V - in August, and is in the process of rolling it out across the country. More than 150,000 people have already received it.

The efficacy of Russia’s Sputnik V vaccine is 91 percent, based on the analysis of the final control point from its Phase 3 trials, its developers said Monday. The calculation was based on data obtained 21 days after the first dose in trial of 22,714 volunteers, the Russian Direct Investment Fund and the Gamaleya Center said in a statement.

No unexpected adverse events were identified, the developers said, adding that the data will be published in a peer-reviewed journal.

Czech Republic 

The Czech Republic reintroduced measures to combat a surge in coronavirus cases, reversing a decision two weeks ago to relax restrictions as neighbor Germany imposed a hard holiday lockdown.

The government shut hotels and restaurants, prolonged Christmas school holidays and imposed an 11 pm to 5 am curfew, according to Health Minister Jan Blatny. Shops and services will remain open. The cabinet approved an additional 10 billion-koruna (US$460 million) aid package to cover rent and wages of the affected businesses for three months.

France

French schoolchildren will be allowed to skip classes and stay at home on Thursday and Friday if their families wish to self-isolate ahead of Christmas, Prime Minister Jean Castex said on Tuesday.

The medical council advising the government on COVID-19 said on Monday that families who planned to host people vulnerable to the coronavirus, such as elderly relatives, should quarantine for a week beforehand if possible.

Schools should not punish pupils who missed the last two days of the academic term, the council added.

The number of hospitalized coronavirus patients in France increased for the third day in a row, according to the latest data from health authorities.

The country's COVID-19 hospitalizations rose by 242 to 25,481 on Monday, while those in intensive care went up by 35 to 2,906.

Also on Monday, France recorded 3,063 new COVID-19 cases in the last 24 hours, sharply down from 11,533 a day before, but case numbers generally fall on Mondays as fewer tests are conducted on Sundays.

The cumulative number of cases in France now totaled 2,379,915. With one-day increase of 371, a total of 58,282 patients have lost their lives to the virus.

France will enter a second phase of easing lockdown rules from Tuesday. People will move freely between regions and can go out without signing documents. A curfew from 8 pm to 6 am will replace a country-wide confinement introduced in late October.

Spain 

Spain confirmed on Monday 2,448 new COVID-19 cases in 24 hours, taking its total caseload to 1,751,884, according to the country's health ministry.

The ministry said the country's total death toll stands at 48,013.

"Our great horizon of hope to combat the pandemic is the proximity of vaccines," Health Minister Salvador Illa Roca said on Thursday while briefing the Congress on the vaccination strategy.

Romania 

Romania reported on Monday 3,252 new cases of COVID-19, bringing its total infections to 559,587, according to official statistics.

The country also reported 109 new deaths from the virus, and the total death toll now stands at 13,494, said the Strategic Communication Group, the official novel coronavirus communication task force.

Romania has decided to extend the state of alert to contain the COVID-19 outbreak by 30 days until Jan. 13, the government announced on Friday.

Denmark

Denmark may expand local lockdowns to the entire country to counter a rise in cases, local media including TV2 reported. The restrictions currently cover two-thirds of Denmark. The government is expected to present the new measures at a press conference later on Tuesday, according to the broadcaster.

Denmark registered 3,337 new COVID-19 cases over the past 24 hours, bringing the nationwide tally to 113,095, said the Danish health authority on Monday.

The country also reported nine new deaths from the virus, taking its national count to 950.

Croatia 

Croatia recorded 1,472 new cases of COVID-19, bringing the total number of confirmed cases to  177,358, said the Croatian Institute of public health on Monday.

The disease has killed 2,705 people in the country, including 65 in the past 24 hours, it added.

A COVID-19 patient remains at the Intensive Care Unit of the Alberto Sabogal Sologuren Hospital, in Lima, on July 02, 2020, amid the new coronavirus pandemic. (ERNESTO BENAVIDES / AFP)

Sweden

Sweden failed to protect elderly people during the pandemic with the high level of community spread likely the biggest factor as the coronavirus ravaged ill-prepared nursing homes, according to an initial report by an official commission on Tuesday.

In the commission’s first findings, it said the overall spread and previously known structural problems within the elderly care system, for which the current and previous governments were ultimately responsible, were to blame for the many deaths.

The commission also said measures by the government and governmental agencies to protect the elderly during the spring had come too late. “We also asses that the measures were insufficient in several respects,” it added.

Sweden’s capital is considering shelving all non-essential healthcare services to free up resources needed to tackle the relentless rise in COVID-19 cases.The redeployment would help Sweden tackle the “historically high” health-care needs its citizens are facing during the pandemic. 

Almost all of Sweden’s regional hospitals are now struggling with a shortage of healthcare staff, according to a report in Swedish Radio.

University hospitals across the country, with the single exception of Norrland University Hospital in Sweden’s northernmost region, no longer have enough employees to look after the sickest COVID-19 patients, the broadcaster said.

Sweden's COVID-19 hospitalizations hit a record high with a total of 2,389 patients in hospitals, 65 more than the previous peak registered in mid-April, local media reported on Monday.

The record was set on Monday as Sweden brought in new national recommendations, replacing regional guidelines for containing the spread of the coronavirus, Swedish Television reported.

The new recommendations place more responsibility on the individual to practice social distancing and hygiene routines.

Portugal 

Portugal on Monday reported 2,194 new coronavirus cases over the past 24 hours, bringing the national tally to 350,938, the country's Directorate-General of Health reported.

Meanwhile, 90 more COVID-19 deaths were recorded, taking the country's death toll to 5,649, the health authority said. 

Lithuania

Lithuania's new government has extended the existing nationwide COVID-19 lockdown till Jan. 31 and will tighten restrictions on movement till Jan. 3 in light of the spike in infections, local media reported on Monday.

From Wednesday, residents are permitted to leave home only for work, essential shopping, caring for the sick, seeking healthcare and attending funerals. Families are allowed to take walks in open spaces.

Social contacts are limited to one family or one household, and events involving more than one household are also banned.

All non-essential shops will have to close or switch to online service. Educational establishments will work remotely with some rare exceptions.

Greece 

Greece reported 639 new COVID-19 cases, bringing the national total to 125,173, authorities announced on Monday.

Meanwhile, the country's death toll from the virus increased by 62 to 3,687, according to the National Public Health Organization.

The country has decided to extend lockdown measures to Jan. 7 in an attempt to further curb the spread of the COVID-19 pandemic. 

Poland 

Poland confirmed on Monday 4,896 new COVID-19 cases, bringing the country's total caseload to 1,140,572, according to the health ministry.

The ministry also announced 96 new deaths from the virus, and the national death toll climbed up to 22,960.

Polish Prime Minister Mateusz Morawiecki said recently that Poland had signed contracts with various vaccine developers for the delivery of 45 million doses.

Serbia 

Serbia reported on Monday 4,932 new COVID-19 cases in the past 24 hours, bringing the nationwide tally to 271,364, according to information released by the country's Institute for Public Health.

The country also reported 49 new deaths from the virus, and the total death toll in Serbia reached 2,380, according to the institute.

Serbia has so far tested over 2 million people, with most tests conducted at specialized "Fire Eye" laboratories built in cooperation with the Chinese BGI group.

Belgium 

Belgium reported on Tuesday 1,074 new COVID-19 cases over the past 24 hours, bringing its national tally to 609,211, according to the public health institute Sciensano.

It also reported 103 coronavirus-related deaths, taking the country's death toll from the disease to 18,054.

Belgian Prime Minister Alexander De Croo said last week that Belgium's COVID-19 figures will be good enough for current restrictions to be eased "in mid-January."

Cananda

Canada will spend C$485 million (US$380 million) to support COVID-19 tests, treatments and vaccines in low- and middle-income countries, including antibody treatments, International Aid Minister Karina Gould said in a statement on Monday.

The funds will make it possible for the United Nations children’s agency UNICEF buy up to 3 million courses of antibody treatments, pending approval.

Two such treatments have been authorized for emergency use in the United States: one from Eli Lilly and AbCellera and another from Regeneron Pharmaceuticals.

Argentina 

Argentina's government aims to vaccinate 30 million people, or more than two-thirds of the population, against the novel coronavirus (COVID-19) disease in 2021, Defense Minister Agustin Rossi said Monday.

Argentina on Monday reported 5,062 new COVID-19 cases, bringing its national tally to 1,503,222, said the country's Ministry of Health.

The ministry also said that 275 more patients have died of the disease, raising the nationwide death toll to 41,041.

A total of 1,340,120 patients have recovered, while 122,061 cases remain active, it added.

Buenos Aires Province has registered a total of 639,561 cases and remains to be the most infected region in the South American country.

The Argentine government has extended the "Social, Preventive and Obligatory Distancing" measures to Dec. 20 to mitigate the spread of the disease. 

Brazil 

Brazil on Monday reported 433 deaths from the novel coronavirus (COVID-19) disease in the last 24 hours, raising the death toll to 181,835.

According to the Ministry of Health, in the same period, tests detected 25,193 new cases of infection, bringing the total caseload to 6,927,145 since Latin America's first case was detected Feb. 26 in Sao Paulo, capital of Brazil's southeast Sao Paulo state.

Sao Paulo state, home to some 46 million inhabitants, has registered 44,050 COVID-19 deaths and 1,337,016 cases.

Shoppers and pedestrians walk along Oxford Street in central London on Dec 14, 2020, as it is announced that Greater London will be moved into Tier 3 from Tier 2 from Wednesday Dec 16. (PHOTO / AFP)

Ecuador 

Ecuador will launch a COVID-19 vaccination pilot project from January to February 2021, before rolling out mass immunization, Deputy Health Minister Xavier Solorzano said Monday.

The pilot program will prioritize high-risk groups, such as healthcare workers and people over 55 years of age who reside in elderly-care homes, he said.

"We are working on being able to make an initial vaccination pilot project perhaps at the end of January, beginning of February," Solorzano said in an interview with a local radio station.

Peru 

Peru has confirmed 790 new COVID-19 cases in 24 hours, taking its total caseload to 986,130 as of 10 p.m. Sunday (0300 GMT Monday), according to the country's health ministry.

The ministry also reported 77 more deaths from the virus, raising the total death toll to 36,754.

Peru is seeing an increase in novel coronavirus (COVID-19) infections among young people aged 18 to 29, reporting 190,515 such cases between March and December, local media said on Monday, citing a report released by the Health Ministry.

In the last two weeks, 5,609 COVID-19 infections were recorded among young people in the South American country, a cause for concern among authorities wary of a possible second wave of cases.

"The issue of these young people is that they are transmitters, vehicles of the virus, and live with the elderly -- that is the fear," the report said.

Chile

Chile will begin vaccinating its population against the novel coronavirus (COVID-19) disease in the first three months of 2021, starting with high-risk groups, Health Minister Enrique Paris said Monday.

"We are going to start vaccinating in the first quarter of 2021 ... To cover the entire population of Chile, we have to vaccinate at least 80 percent of the population," Paris said at a press conference.

However, due to logistical challenges, such as distribution, "we are not going to have 80 percent of the population vaccinated with an effective vaccine to fight this virus before June 30," he added.

The Ministry of Health reported 1,911 new daily cases of COVID-19, which pushed the accumulated caseload to 573,830 since the onset of the outbreak in mid-March.

Panama 

Panama confirmed 1,612 new COVID-19 cases on Monday, bringing its nationwide tally to 194,619, the Ministry of Health reported.

The country also reported 26 new deaths from the virus, taking its total death count to 3,382.

Mexico 

Mexico reported 5,930 new COVID-19 cases  on Monday, bringing the national total to 1,255,974, according to the health ministry.

Meanwhile, the country's death toll from the virus increased by 345 to 114,298.

Mexico ranks fourth among Latin American countries in terms of documented COVID-19 cases, following Brazil, Argentina and Colombia.

The country has the world's fourth highest COVID-19 death toll, after the United States, Brazil and India.

Morocco 

Morocco registered 1,217 new COVID-19 cases on Monday, taking the tally in the North African country to 400,826, the health ministry said in a statement.

It also reported 35 new deaths from the coronavirus, raising the death toll in Morocco to 6,659.

Libya

The National Center for Disease Control of Libya on Monday reported 578 new COVID-19 cases, bringing the total confirmed cases in the North African country to 91,357.

The Center said in a statement that 558 more patients recovered, raising the total recoveries to 61,453, while the death toll hit 1,314 with 15 new fatalities.

Since the first case was reported in March, Libyan authorities have taken a series of precautionary measures against the pandemic, including closing the country's borders, shutting down schools and mosques, banning public gatherings and imposing a curfew.