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Published: 18:11, October 22, 2021 | Updated: 18:21, October 22, 2021
Astra COVID-19 shot found safe for pregnancy, fertility in study
By Agencies
Published:18:11, October 22, 2021 Updated:18:21, October 22, 2021 By Agencies

This photo shows a general view of the offices of British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca PLC in Macclesfield, Cheshire on July 21, 2020. (PAUL ELLIS / AFP)

GENEVA / THE HAGUE / WINDHOEK / WASHINGTON / BRUSSELS / MOSCOW / ZURICH / YAOUNDE / BERLIN - AstraZeneca Plc’s COVID-19 vaccine has no adverse impact on pregnancy or fertility, according to data from a small group of trial participants who conceived during a study.

The rate of miscarriage was roughly the same between the vaccine and placebo groups, and no still births or neonatal deaths were recorded, according to an analysis of the outcomes published in The Lancet medical journal late Thursday. Fertility was also shown to be unaffected by the vaccine.

The review looked at four trials from the study spanning the UK, Brazil and South Africa. 

People who were already pregnant were excluded from taking part. Ninety-three volunteers who became pregnant during the study were included in a fertility analysis - 50 who’d received the vaccine and 43 the placebo. The result showed no impact on fertility from the shot.  

In total, 107 pregnancies were assessed for outcomes. Fifteen live births occurred during the analysis - 10 in the vaccine group and 5 in the placebo. Three babies from the vaccinated arm were born prematurely, but all in the late preterm stage between 34 and 37 weeks of gestation.

A lack of clinical data on the impact of the coronavirus vaccines in pregnancy has led to hesitancy among pregnant people to take the shots, despite the increased risk of contracting severe COVID-19 in this population.

“With increasing availability of misinformation, which continues to affect vaccine uptake, these data, along with published data on mRNA vaccines, can provide evidence to support women in making decisions regarding vaccination,” said the authors, who are mainly from the vaccine’s co-developer, the University of Oxford.

Expectant mothers are often excluded from trials because of safety concerns. Pfizer started one to assess the impact of its vaccine on the pregnant population earlier this year, but the study was delayed by slow enrollment after US government guidance changed, recommending vaccination in pregnancy.

Cameroon

Cameroon will inoculate all personnel on state payroll against COVID-19 next month as part of its nationwide vaccination program, a government minister has said.

The civil servants will be vaccinated from Nov 6 to 30, Minister of Public Service and Administrative Reform Joseph Le said Thursday.

"The preservation of the health of personnel at the service of the state is both a major concern and a duty of public authorities," he said. "We must ensure that the work environment is not a place where the virus spreads, but a framework for professional development and health promotion for all."

Le said vaccination will not be compulsory but urged all civil servants to get vaccinated to protect themselves and their loved ones.

On Wednesday, the United Nations Office for the Coordination of Humanitarian Affairs in Cameroon, quoting government statistics, said the central African nation reported 4,024 positive cases from Sept. 21 to 28, the highest weekly count since March, and raised an alert on the presence of the Delta variant.

This file photo dated April 20, 2021 shows an exterior view of the European Medicines Agency (EMA) in Amsterdam, the Netherlands. (PETER DEJONG / FILE / AP)

European Medicines Agency (EMA)

The European Union's drug regulator expects to announce the results of its review of Moderna's COVID-19 booster vaccine next week and also to start a rolling review of Merck's (MRK.N)antiviral oral pill, a senior official said on Thursday.

The results of the Moderna review will be announced on Oct 25, Marco Cavaleri, head of vaccines strategy for the European Medicines Agency (EMA), told a briefing.

The EMA's conclusion on boosters of Moderna's vaccine, Spikevax, is expected for use in people over 12 years of age and the shot is to be given six months after a second dose.

The EMA said it expected to receive data on boosters of the single-shot Johnson & Johnson vaccine in the coming weeks.

A funeral worker carries a coffin cover for a patient who died of COVID-19 at Infectious Hospital No. 5 in Nizhny Novgorod, Russia, on Oct 20, 2021. (ROMAN YAROVITCYN / AP)

European Union

A systematic disinformation campaign in Russian media to foster doubts and misgivings about COVID-19 vaccines in the West has backfired as the death toll in Russia rises to record daily tolls, a European Union report said on Thursday.

The EU study said Russian state broadcaster RT and other media outlets had sown mistrust about the efficacy and safety of vaccines on their European websites in a number of languages, including Russian.

"Disinformation can kill. That should be kept in mind when we see Kremlin media continue spreading lies on COVID-19 and the vaccines, even as the death tolls in Russia are surging," said the EU study, entitled "Disinformation Review".

The Kremlin denies all disinformation allegations by the EU, which produces regular reports and seeks to work with Google, Facebook, Twitter and Microsoft to limit the spread of fake news.

The EU has documented what it says is Russian disinformation since early on in the pandemic in January 2020, via the bloc's foreign service EEAS. It is part of what the EU says is a broader Russian effort to weaken and divide Western societies.

ALSO READ: COVID-19: Pfizer, BioNTech say booster restores full protection

Citing its own database on disinformation, the EU study said it found over 250 cases by Russian outlet Geopolitica.ru that sought to ridicule COVID-19 vaccinations and other measures.

"The claim of the uselessness of the vaccine is repeated in Italian, in Spanish, in English, in Dutch, and in Russian," the study found.

"The vaccines work. But the lies work as well," the EU report showed, noting "a chorus of false claims and conspiracy theories on the vaccine ... risking the lives of thousands uponr thousands of people, internationally and in Russia."

Global tally

Coronavirus cases worldwide surpassed 242.59 million while the global death toll topped 4.93 million, according to data compiled by Johns Hopkins University.

Medical staff walks in front of a COVID-19 test station in Hemmelsdorf, northern Germany, on Oct 19, 2021. (MICHAEL PROBST / AP)

Germany

A key measure of coronavirus infections in Germany rose sharply over the past week, figures showed on Friday, raising the prospect of tougher restrictions as winter approaches.

The seven-day incidence rate of cases - which has been used to decide COVID-19 curbs - jumped more than 26 points in a week, the Robert Koch Institute responsible for disease control said.

The rise comes as the leaders of Germany's 16 states are discussing pandemic plans. A nationwide state of emergency is set to lapse on Nov. 25, meaning restrictions will automatically expire then unless extended by parliamentary vote.

The number of new infections per 100,000 people over seven days stood at 95.1 compared with 68.7 reported a week ago, the institute said.

A total of 19,572 new infections were reported on Friday, 8,054 more than the same time last Friday, it added.

More than 1,500 COVID-19 patients are in intensive care, up from about 1,400 a week ago, figures from the DIVI association for intensive and emergency medicine showed on Thursday.

"The fourth wave has started now and is still gaining speed," Christian Karagiannidis, the scientific head of DIVI, said on Twitter on Thursday.

Germany's state premiers are unlikely to lift rules requiring social distancing, mask-wearing and proof of vaccination, recovery or a negative test result to enter most indoor public spaces.

Namibia

Namibia's Ministry of Information and Communication Technology (MICT) together with the country's Ministry of Health and Social Services jointly activated a countrywide roadshow campaign, dubbed "Get vaccinated, Kick COVID-19 out of Namibia," on Thursday in Windhoek.

Activation events across the rest of the country are set to run from Oct 25 to Dec 10, aimed at vaccinating between 150,000 to 400,000 individuals during this period, MICT said in a statement.

Various vaccination sites in all the 14 regions will be visited by high-level political office bearers and officials from different ministries and agencies for public mobilization, according to the statement.

Netherlands

The number of new COVID-19 cases in the Netherlands exceeded 5,000 between Wednesday and Thursday, the largest single daily total in three months, the National Institute for Public Health and the Environment (RIVM) said on Thursday.

The RIVM reported 5,223 new coronavirus infections, compared to 4,602 positive tests in the 24 hours from Tuesday to Wednesday. Seven people died from COVID-19 in the past 24 hours, compared to four reported deaths a day earlier.

In its latest weekly count, the RIVM said that between Oct 12 and Oct 19, 25,751 people tested positive for COVID-19, a week-on-week increase of 44 percent. Increases were reported in all regions and age groups.

According to the RIVM, the fresh spike in infections was related to the relaxation of the COVID- measures over three weeks ago and to the seasonal effect.

Needles preloaded with the Moderna and Pfizer-BioNTech COVID-19 vaccines sit in baskets awaiting patients at a vaccine clinic at Hartford Hospital in Hartford, Connecticut, US, on Aug 24, 2021. (JOSEPH PREZIOSO / AFP)

Pfizer/BioNTech

Pfizer and BioNTech announced Thursday that a large-scale trial of their COVID-19 vaccine booster showed it restored full protection against the disease.

In a Phase 3 randomized, controlled trial, a Pfizer-BioNTech booster dose was administered to more than 10,000 individuals 16 years of age and older, who previously received the Pfizer-BioNTech primary two-dose series.

It showed a relative vaccine efficacy of 95.6 percent when compared to those who did not receive a booster.

These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial.

"These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease," said Albert Bourla, Pfizer chairman and chief executive officer.

A woman wearing a face mask walks in Moscow on Oct 5, 2021. (DIMITAR DILKOFF / AFP)

Russia

Russia on Friday reported yet more daily records of COVID-19 infections and deaths, with 37,141 new cases and 1,064 people dying in the past 24 hours.

It was the second successive daily case record and the fourth straight day of record deaths this week, a surge that has prompted authorities to reintroduce restrictions and renew calls for people to get vaccinated.

Meanwhile, the state consumer watchdog's senior researcher said on Thursday that Russia has reported "isolated cases" of COVID-19 with a subvariant of the Delta variant that is believed to be even more contagious.

The researcher, Kamil Khafizov, said the AY.4.2 subvariant may be around 10 percent more infectious than the original Delta - which has driven new cases and deaths to a series of record daily highs in Russia - and could ultimately replace it.

However, he said this was likely to be a slow process.

ALSO READ: Putin orders new restrictions with COVID-19 deaths at record

The AY.4.2 subvariant is also on an increasing trajectory in England and had already accounted for about 6 percent of all sequences generated on the week beginning Sept 27, a UK Health Security Agency report released on Oct 15 said. 

Russian immunologist Nikolay Kryuchkov said Delta and its subvariants would remain dominant and might in the future adapt in some ways to vaccines, especially where vaccination rates are below or just above 50 percent.

People queue at a COVID-19 test center installed in a street of Swiss capital Bern on Sept 17, 2021. (FABRICE COFFRINI / AFP)

Switzerland

Swiss voters look set to support the government's pandemic response plan in a binding referendum next month, a poll for broadcaster SRG showed on Friday.

The gfs.bern survey found 61 percent backed a law passed in March that expanded financial aid to people hit by the COVID-19 crisis and laid the foundation for certificates the government requires to facilitate travel abroad and allow certain events to be held.

The survey found 36 percent opposed and 3 percent were undecided before the Nov 28 referendum under the Swiss system of direct democracy. The poll's margin of error was 2.8 percentage points.

In two other votes that day, the Swiss would easily support a labour union-backed proposal to boost the nursing profession, the poll found.

A man wears a face mask as he walks in Piccadilly Circus, in London on Oct 19, 2021. (ALBERTO PEZZALI / AP)

UK

The UK is reporting numbers of new coronavirus cases not seen since the summer as the government comes under pressure to reimpose restrictions.

Just over 52,000 tests were reported to have come back positive on Thursday, the most since July 17. While the number of people in hospital with the disease crossed 8,000, more than a thousand more than a week earlier.

A strong vaccine rollout in the UK means daily deaths still remain relatively low compared to more than 1,800 recorded at the beginning of this year.

The government is coming under pressure to enact “Plan B”, which could require face masks in public, encourage work from home and enforce social distancing.

Separately, the UK drug regulator added an extremely rare nerve-damaging disorder, Guillain-Barré syndrome (GBS), as a very rare side effect of the AstraZeneca COVID-19 vaccine, updates on the agency's website showed on Thursday.

Medicines and Healthcare products Regulatory Agency's (MHRA) decision comes after the European medicines agency added GBS as a possible side-effect last month.

This file photo on Apr 23, 2020 shows a general view of the Centers for Disease Control headquarters in Atlanta, Georgia, US. (TAMI CHAPPELL / AFP)

United States

The US Centers for Disease Control and Prevention (CDC) on Thursday recommended the COVID-19 vaccine boosters for recipients of the Moderna Inc and Johnson & Johnson shots, and said Americans can choose a different shot from their original inoculation as a booster.

CDC director Rochelle Walensky signed off on the recommendations late on Thursday, aligning the agency with the US Food and Drug Administration's authorization on Wednesday for the additional boosters and "mix-and-match" dosing.

Walensky said that vaccines authorized in the United States "are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant" of the coronavirus.

A panel of advisers to the CDC had unanimously backed COVID-19 vaccine boosters earlier on Thursday.

Still, health officials and public health experts said the booster rollout could be confusing.

The panel struggled with trying to make the language of its recommendations as clear as possible, and also offer flexibility for patients to get a vaccine of their choice.

"A really important aspect of all of this is being clear and not dancing on the head of a pin, so that we don't further confuse the American people," said Dr. Beth Bell, a panel member and clinical professor in the department of global health at the University of Washington in Seattle.

The recommendations also open the door for recipients of the one-shot J&J vaccine to get a dose of the Pfizer or Moderna vaccines that have been shown to afford greater protection in a variety of studies.

This photo taken on April 2, 2019 shows the WTO logo on the main gate of the World Trade Organization (WTO) in Geneva, Switzerland. (PHOTO / XINHUA)

In another development, the White House on Thursday called on all World Trade Organization members to support an intellectual property waiver for COVID-19 vaccines.

"We ... need every WTO member to step up as well and support an intellectual property waiver, and every company must act ambitiously and urgently to expand manufacturing now," White House spokesperson Karine Jean-Pierre told reporters.

A year after South Africa and India introduced a proposal to temporarily waive intellectual property rights on COVID-19 vaccines and therapies at the WTO, negotiations have failed to make any progress.

More than 100 countries backing the waiver say it will help save lives by allowing developing countries to produce COVID-19 vaccines, but the European Union and several countries, including Switzerland, remain opposed.

WTO Director-General Ngozi Okonjo-Iweala last week conceded the formal negotiations about a temporary waiver were "stuck," but said she believed informal talks were intensifying.

World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus attends a press conference in Kuwait City, Kuwait, on July 28, 2021. (PHOTO / XINHUA)

WHO

The World Health Organization has urged countries to prioritize vaccination for health workers in the light of its new paper estimating that 115,000 died from coronavirus between January 2020 and May 2021.

Although data from 119 countries suggests that on average two in five health workers globally are fully vaccinated, there are nonetheless huge differences across regions and economic groups, said WHO Director-General Dr. Tedros Adhanom Ghebreyesus at a press briefing on Thursday.

For example, WHO's data shows that less than one in ten health workers in Africa has been fully vaccinated, while in most high-income countries more than 80 percent of health workers are fully vaccinated.

According to the International Council of Nurses (ICN), WHO had been informed by governments of less than 7,000 COVID-related healthcare worker deaths during that period. However, WHO and ICN analyzed this information, and arrived at an estimate of 115,000 deaths among health workers globally - which ICN warns is a conservative estimate.

Meanwhile, more social mixing indoors after the lifting of restrictions just as winter sets in is driving a rise in COVID-19 infections in many countries across Europe, the World Health Organization's emergency director Mike Ryan said on Thursday.

"Most of those restrictions are now not in place anymore in many countries. And we're seeing that coincide with the winter period in which people are moving inside as the cold snaps appear," Ryan told a news briefing. "The question remains as to whether or not we will have the same experience as last year with health systems coming once again under pressure."

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