EU regulator finds mRNA virus shots safe during pregnancy

Employees in cleanroom suits test the procedures for the manufacturing of the messenger RNA (mRNA) for the COVID-19 vaccine at the new manufacturing site of German company BioNTech on March 27, 2021 in Marburg, central Germany.
(THOMAS LOHNES / AFP)

COPENHAGEN / PARIS / WARSAW / HAVANA / LJUBLJANA / BRUSSELS / ROME / HARARE / RIGA / KAMPALA / LUSAKA / BERLIN / OTTAWA – COVID-19 vaccines made using mRNA technology do not cause pregnancy complications for expectant mothers and their babies, the European Union's drug regulator said on Tuesday, following a detailed review of several studies.

The review based on studies involving around 65,000 pregnancies at different stages did not find any sign of higher risk of complications, miscarriages, preterm births or severe side-effects on the unborn babies from mRNA shots, the European Medicines Agency said.

Pfizer and German partner BioNTech, as well as Moderna, currently supply such vaccines to the European Union.

While the EMA acknowledged some limitations in the data, it said results were consistent across studies.

"The benefits of receiving mRNA COVID-19 vaccines during pregnancy outweigh any possible risks for expectant mothers and unborn babies," the agency said.

The review by an internal team also found that COVID-19 shots are as effective at cutting the risk of hospitalization and death in pregnant people as in non-pregnant people.

Several EU countries have already endorsed the use of COVID-19 vaccines for pregnant people, and the EMA's backing of mRNA shots is likely to bolster vaccination campaigns in smaller nations that rely on the regulator's scientific expertise.

Moderna

Moderna Inc's vaccine candidate against the Omicron coronavirus variant will enter clinical development in the next few weeks and the company expects to be able to share data with regulators around March, CEO Stephane Bancel said on Monday.

"The vaccine is being finished … it should be in the clinic in coming weeks. We are hoping in the March timeframe to be able to have data to share with regulators to figure out next steps," Bancel said at the World Economic Forum's virtual Davos Agenda conference.

Moderna is also developing a single vaccine that combines a booster dose against COVID-19 with its experimental flu shot. 

Bancel said the best case scenario was the combined COVID-19/flu vaccine would be available by the fall of 2023, at least in some countries.

"Our goal is to be able to have a single annual booster so that we don't have compliance issues where people don't want to get two to three shots a winter."

A worker takes information from a driver during a COVID-19 vaccine drive through clinic at St. Lawrence College in Kingston, Ontario, Canada on Dec 18, 2021. (LARS HAGBERG / THE CANADIAN PRESS VIA AP)

Canada

Canada on Monday approved Pfizer Inc's oral antiviral treatment for mild to moderate cases of COVID-19 in adults, but said global supply shortages meant only a few doses would be ready now.

Rising infections and hospitalizations due the Omicron variant are forcing provinces to put in restrictions and the federal government to support impacted businesses. Officials predict COVID-19 cases will soar in coming weeks.

"(This approval) is particularly important, as access to easy to use treatments could help to reduce the severity of COVID-19 in adults who become newly infected," chief public health officer Theresa Tam told reporters.

Ottawa said last month it had signed a deal with Pfizer for a million treatment courses, pending approval. A global shortage means only a fraction will arrive soon.

Canada has received 30,400 courses and officials said it will take delivery of another 120,000 by end-March.

"We're among the first countries to have approved the medication but also to have received the medication … competition is high and we are doing a good job," Federal Health minister Jean-Yves Duclos told a separate briefing.

Pfizer's two-drug antiviral regimen, Paxlovid, was nearly 90 percent effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to clinical trial data.

It is meant to be taken at home for five days beginning shortly after onset of symptoms.

Official data show that as of Jan 8, 87.8% of Canadians aged 12 and older had received two doses of a COVID-19 vaccine.

A girl gets a dose of the Cuban made Soberana-02 vaccine for COVID-19 in Havana, Cuba, Aug 24, 2021. (RAMON ESPINOSA / AP)

Cuba

Cuba on Monday surpassed one million cases of COVID-19 since the pandemic first hit the island in March 2020, the Health Ministry said.

The milestone came after the Caribbean nation registered 3,306 new cases of COVID-19 and one more related death in the previous 24 hours, raising the nation's caseload to 1,002,499 and the pandemic death toll to 8,341.

According to the ministry, there are currently 17,443 active cases.

Cuba's eastern province of Holguin registered the highest number of daily coronavirus cases (419), followed by the provinces of Pinar del Rio (278) and Camaguey (257).

To date, more than 87 percent of Cubans have been fully jabbed against coronavirus with homegrown vaccines, the ministry said. 

An election committee member wearing a protective equipment as a preventive measure against the coronavirus COVID-19 disease is pictured at a drive-in polling station for quarantined voters, on Oct 06, 2021 in Prague, ahead of the country's general election. (MICHAL CIZEK / AFP)

Czech Republic

The Czech Republic reported on Tuesday more than 20,000 new cases of COVID-19, the biggest single-day rise since Dec 1, the Health Ministry said.

The central European country of 10.7 million is bracing for a new wave of the pandemic as the Omicron variant of the coronavirus begins pushing up cases.

The government has shortened quarantine and isolation times as part of new measures while also launching mandatory testing of employees at companies, which got underway this week.

On Monday, the Health Ministry recorded 20,270 new coronavirus infections, up from 7,342 a week earlier.

Hospitalizations, which peaked above 7,000 in early December in the last wave, stood at 1,660 on Monday, up a touch from Sunday.

An employee at a Nordisk Film cinema in the center of Copenhagen on May 6, 2021 checks the "Corona pass” of a customer as they come to watch a film on the first day that movie theaters in the Danish capital reopened after being closed due to COVID-19 restrictions. (TOM LITTLE / AFP)

Denmark

Denmark registered a record number of coronavirus infections on Monday, as cinemas, museums and other cultural institutions reopened after a month-long COVID-19 lockdown.

The Nordic country registered 28,780 new cases in the space of 24 hours and the number of coronavirus-related hospitalizations rose to 802, the highest in a year.

Still, health authorities said earlier this month that the now-predominant Omicron variant was milder than initially thought and that around 29 percent of those in hospital were there due to reasons other than COVID-19.

Since a peak of 82 on Jan 6, the number of COVID-19 patients in intensive care has fallen steadily to 52 on Monday.

As a consequence, lawmakers last week agreed to ease restrictions, including reopening theatres, cinemas, museums, entertainment parks and botanic gardens, and allow limited spectators at indoor and outdoor sports events.

European Commission President Ursula von der Leyen delivers a statement on  COVID-19 pandemic at the European Commission headquarters in Brussels, Belgium on Nov 26, 2021. (JOHANNA GERON / POOL PHOTO VIA AP)

European Union

European Commission President Ursula von der Leyen said on Monday that she had canceled her appointments at the European Parliament in Strasbourg this week after her driver tested positive for COVID-19.

"My driver has tested positive for COVID19. Regretfully, I must therefore cancel my participation in the European Parliament plenary. I am returning to Brussels," she said on Twitter.

According to her calendar, publicly available on the European Commission website, Von der Leyen was meant to be in Strasbourg until Wednesday.

On Wednesday, von der Leyen was to preside over a meeting of the College of Commissioners and then participate in the EP plenary debate on the presentation of the program of activities of the French Presidency.

A couple holds each other at a COVID-19 intensive care unit of the la Timone hospital in Marseille, southern France on Dec 23, 2021. (DANIEL COLE / AP)

France

The number of people with COVID-19 in French hospitals rose by 888 to 25,775, the health ministry said on Monday, the biggest one-day increase since early November 2020 – before the start of the country's vaccination campaign.

The last time the number of COVID-19 patients was over 25,000 was on Dec 17, 2020.

Health ministry data on Monday also showed that the number of people with COVID-19 in intensive care units rose by 61 to 3,913, after being flat to stable for four days.

On Sunday, the ministry reported more than 278,000 new infections, which was a decline of 6 percent against a week earlier and the first week-on-week fall this year.

On Sunday, the seven-day moving average of new infections fell to 294,452, after setting a record high of just over 297,000 on Saturday. That was the first fall time since mid-November, when new infections averaged around 10,000 per day.

On Monday, the ministry reported 102,144 new cases and the seven-day average again rose slightly to 295,631. It also reported 296 new deaths, taking the total to 127,263.

In this file photo taken on Dec 23, 2021, a girl is inoculated against coronavirus COVID-19 during a children's vaccination action in the the Red City Hall in Berlin, Germany. (TOBIAS SCHWARZ / AFP)

Germany

Germany recorded a new record high in its seven-day COVID-19 incidence rate which rose to 528.2 new infections per 100,000 people, from 375.7 last week, the Robert Koch Institute (RKI) for infectious diseases said on Monday.

The RKI registered 34,145 infections in the last 24 hours, around 8,900 more than last week. Last Friday, daily COVID-19 infections in Germany exceeded 90,000 for the first time since the pandemic began.

As of Sunday, 72.7 percent of the country's population had been fully vaccinated, with at least 39.2 million booster shots administered, according to official figures. However, 20.7 million people in Germany are still unvaccinated.

Latvia

Latvia recorded the highest rate of COVID-19 infections over the last 24 hours, the country's Center for Disease Prevention and Control (CDC) said on Monday.

The CDC reported 1,560 new coronavirus infections, including 668 unvaccinated people and 892 vaccinated.

Of the 7,171 people tested for COVID-19 in the past 24 hours, 21.8 percent turned out to be infected, which is the highest percentage ever recorded in Latvia.

The high rate of infections caused disruptions at many schools in the central Latvian district of Ogre, where 87 student groups and nine preschool groups had to be quarantined, the local authority said.

An elderly couple wearing protective face masks against COVID-19 walks past the Pfizer Inc headquarters on Dec 9, 2020 in New York City. (ANGELA WEISS / AFP)

Pfizer

Pfizer will add a production facility for its antiviral COVID-19 pill in France as part of a plan to invest 520 million euros ($594 million) in the country over the next five years, the US drugmaker said on Monday.

The decision is part of Pfizer's strategy to boost global production of the pill, paxlovid, which was found to be nearly 90 percent effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to clinical trial data.

The investment will initially involve the production of active pharmaceutical ingredient (API) for paxlovid at a plant run by French pharmaceutical group Novasep, Pfizer said, noting that additional Novasep facilities will be added next year.

"Novasep will produce API for use in our manufacturing network, expected to contribute to the overall (global) effort to produce 120 million courses of treatment in 2022," it added.

The drug obtained emergency approval from the US drug regulator in December, and is being assessed for possible authorisation in the European Union.

Pfizer said it expected Novasep's plant in Mourenx, in south-west France, to be incorporated into its global paxlovid supply chain in the third quarter of this year, with production being expanded to include other Novasep facilities in 2023, a spokesman said.

A woman receives a vaccination certificate after receiving a booster shot against COVID-19, in Warsaw, Poland on Dec 7, 2021.  (CZAREK SOKOLOWSKI / AP)

Poland

Poland is experiencing a fifth wave of COVID-19 infections, the health minister said on Monday, warning that the spread of the Omicron variant could send daily case numbers soaring to levels not yet seen in the country.

While daily case numbers have fallen since early December, the European Union's largest eastern member has had little respite since the fourth wave, regularly reporting over 10,000 new infections per day amid low vaccine take-up and limited restrictions on public life.

"We predict that the peak of infections will be in mid-February and that peak is about 60,000 cases a day," Adam Niedzielski told a news conference.

The highest number of daily cases reported since the pandemic began was 35,251 on April 1, 2021.

Niedzielski said that he expected figures released on Tuesday to show in excess of 20,000 daily cases.

Slovenia

 From Wednesday, Slovenia will relax the rules on mandatory self-isolation after being in contact with a positive case of COVID-19, Health Minister Janez Poklukar said on Monday. The government's aim is to keep the country's overburdened hospitals functioning, he said.

Healthcare, social and educational workers who have been in contact with an infected person will no longer have to spend seven days in isolation but will instead have to take a COVID-19 test every day for seven consecutive days after the risky contact and wear an FFP2 mask at work, Poklukar told a news conference.

"From Wednesday, students will also not be obliged to go into self-isolation … but will have to take a COVID-19 test every day for seven days (after a risky contact at school)," Poklukar said.

He said the whole class will have to go into quarantine only if 30 percent of pupils become infected over a period of 14 days. 

A school security guard measures the temperature of the pupils at the entrance of Kitante Primary School in Kampala, Uganda on Jan 10, 2022. (HAJARAH NALWADDA / AP)

Uganda

Uganda has started giving COVID-19 vaccine booster shots to priority groups as the country grapples with a surge in infection levels.

Emmanuel Ainebyoona, health ministry spokesperson told Xinhua by telephone on Monday that the eligible categories include people aged 50 years and above, health workers, teachers, religious leaders, cultural leaders, security personnel, media, and drivers and conductors of passenger service vehicles. 

The others are boda boda riders, bar and nightclub workers, market workers and vendors.

Zambia

Zambia has recorded the lowest daily COVID-19 cases since the emergence of the Omicron variant last month, figures released by the health ministry on Monday have shown.

The country, which has seen a surge in daily cases of over 1,000 in the fourth wave mainly driven by the Omicron variant, recorded 685 new cases in the last 24 hours.

Worshippers have their temperature checked before entering church on Christmas day on the outskirts of Harare, Zimbabwe on Dec 25, 2021. (TSVANGIRAYI MUKWAZHI / AP)

Zimbabwe

Zimbabwe has seen a sharp decline in COVID-19 cases over the past week, with daily cases dropping from 709 on Jan 10 to 144 on Sunday, according to figures released by the Ministry of Health and Child Care on Monday.

Deaths have also consistently declined over the period from 20 per day to 4 deaths on Sunday.

The country began experiencing the Omicron variant-driven fourth wave at the beginning of last month, leading the government to tighten lockdown measures.

Daily cases peaked at 6,181 on Dec 10, and have since then been consistently declining.