Connect with us

coronavirus

Health experts pore over AstraZeneca safety data as Europe reels from vaccine suspensions

Reuters

Published

on

Global health experts came under increasing pressure on Tuesday (16 March) to clear up questions over the safety of AstraZeneca’s COVID-19 shot, as Sweden and Latvia joined countries suspending their use in a further blow to Europe’s vaccination rollout, write Anthony Deutsch and Caroline Copley.

The European Medicines Agency (EMA) said it was investigating reports of 30 cases of unusual blood disorders out of 5 million recipients of the AstraZeneca vaccine. In total, 45 million COVID shots have been delivered across the region.

The EU regulator will release its findings on Thursday but its head, Emer Cooke, said she saw no reason to change its recommendation of AstraZeneca - one of four vaccines that it has approved for use.

“The benefits continue to outweigh the risks, but this is a serious concern and it does need serious and detailed scientific evaluation,” Cooke told a news conference.

A World Health Organization (WHO) committee of experts was reviewing the cases and was expected to issue a statement by the end of the day, a spokesman said.

The EU’s largest members - Germany, France and Italy - suspended use of AstraZeneca’s vaccine on Monday pending the outcome of investigations into unusual cases of a rare cerebral thrombosis in people who had received it.

The addition of Sweden and Latvia on Tuesday brought to 13 the number of EU countries to act since reports first emerged of thromboembolisms affecting people after they got the AstraZeneca shot.

The WHO and EMA had earlier joined AstraZeneca in saying there is no proven link, but some experts said the episodes of blood clots, bleeding and low platelet counts in younger people seemed to indicate a causal connection to the AstraZeneca shot.

“The benefits of vaccination significantly outweigh the risks, especially for the elderly,” said Karl Lauterbach, health spokesman for Germany’s Social Democratic Party.

“But it could be the case that the risks of the vaccine are higher for certain patient groups such as young women,” Lauterbach, an epidemiologist whose party is part of the Berlin coalition, told Deutschlandfunk radio in an interview.

Other epidemiologists note that similar cases have not been found in unusual numbers in Britain, which began using AstraZeneca earlier and has given more than 10 million doses.

“A very likely explanation of at least some of the clotting disorders seen are a result of COVID-19 rather than the vaccine,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine.

“There are published papers that make clear that these problems definitely occur in COVID-19 and there is no doubt that all the vaccines in use prevent that disease. Hence the risk and benefit balance for the AstraZeneca vaccine remains clearly in favour of its benefits.”

Graphics: Vaccine rollout across EU by brand

Reuters Graphic

In the EU’s largest states, including Germany, France, Italy, the Netherlands and Spain, AstraZeneca has accounted for about 13-15% of shots given since the rollout began almost three months ago, with Pfizer-BioNTech making up the majority, according to official data.

As one as the cheapest to be developed, the AstraZeneca shot is set to be the mainstay of vaccination programmes in much of the developing world.

Governments say they acted on the AstraZeneca shot out of an abundance of caution - of 1.6 million people in Germany given the vaccine, seven fell ill with a very rare cerebral vein thrombosis of whom three died.

In a detailed analysis of its findings Germany’s vaccine oversight body, the Paul Ehrlich Institute, said six of the cases were in women of young or middle age - a number statistically significantly higher than normally expected.

Nicola Magrini, the director general of Italy’s medicines authority AIFA, told daily la Repubblica the AstraZeneca shot was safe and its benefit to risk ratio was “widely positive”. There have been eight deaths and four cases of serious side-effects in Italy following vaccinations, he added.

In France, Health Minister Olivier Veran told reporters the risk-reward ratio for the AstraZeneca vaccine remained positive.

A third wave of infection in Europe, driven by more infectious viral variants, threatens to worsen a pandemic that has claimed 575,000 lives in the European Union and further delay recovery from a pandemic economic slump.

Deutsche Bank on Tuesday slashed 2021 economic growth forecasts for the euro area by a whole percentage point, citing spillover of the ongoing pandemic-linked activity restrictions.

Coronavirus infections are rising exponentially in Germany, an expert at the Robert Koch Institute for infectious diseases said, putting at risk plans to lift its lockdown. France is considering a possible third national lockdown.

Vaccination campaigns had got off to a slow start due to scarce supply, but the European Commission said on Tuesday it expects to receive more than 200 million doses of vaccine from Pfizer and BioNTech in the second quarter, putting the EU on course to meet its targets.

The EU aims to vaccinate at least 255 million people, or 70% of its adult population, by the end of the summer. The bloc has administered 11 shots so far for every 100 residents, while Israel - a world leader in vaccination - has given 108 doses, according to Our World in Data.

coronavirus

Coronavirus variants: Commission calls for limiting essential travel from India

Reuters

Published

on

By

The Commission calls on EU member states to take co-ordinated action to further restrict travel from India on a temporary basis, with a view to limiting the spread of the B.1.617.2 variant first detected in India. This follows a proposal of the World Health Organization on 10 May 2021 to change the classification of that variant from “variant of interest” to “variant of concern”. It is important to limit to the strict minimum the categories of travellers that can travel from India for essential reasons and to subject those who may still travel from India to strict testing and quarantine arrangements.

To ensure a fully co-ordinated and efficient response to this variant and taking into account the deteriorating health situation in India, the Commission proposes that member states apply an ‘emergency brake' on non-essential travel from India. On 3 May, the Commission had proposed to add an ‘emergency brake mechanism' to the Council recommendation on restrictions to non-essential travel.

Limited exemptions for those travelling for compelling reasons, subject to strict safeguards

The restrictions should not affect those travelling for compelling reasons such as for imperative family reasons or persons in need of international protection or for other humanitarian reasons. EU citizens and long-term residents, as well as their family members, should still be able to travel to Europe.

For those travellers, the Commission calls on member states to apply additional health-related measures such as strict testing and quarantine arrangements. These measures should apply regardless of whether the travellers have been vaccinated.

Next steps

Any restrictions on essential travel from India should be temporary and regularly reviewed. member states should assess their effectiveness in containing the new variant. When triggering the ‘emergency brake' mechanism to further restrict travel from a non-EU country, the member states meeting within the Council structures should review the situation together in a coordinated manner and in close co-operation with the Commission.

Background

A temporary restriction on non-essential travel to the EU is currently in place from many non-EU countries, including from India, based on a recommendation agreed by the Council.

Following a proposal by the Commission, the Council agreed on 2 February 2021 additional safeguards and restrictions for international travellers into the EU, aimed at ensuring that essential travel to the EU continues safely in the context of the emergence of new coronavirus variants and the volatile health situation worldwide.

On 3 May, the Commission proposed that member states ease the current restrictions on non-essential travel into the EU to take into account the progress of vaccination campaigns and developments in the epidemiological situation worldwide while putting in place a new ‘emergency brake mechanism', to address coronavirus variants. The ‘emergency brake mechanism' is a coordination mechanism intended to limit the risk of variants of interest and variants of concern entering the EU. It allows member states to act quickly and in a coordinated manner to temporarily limit to a strict minimum all travel from a non-EU country where the epidemiological situation worsens quickly and in particular where a variant of concern or interest is detected.

Variants of interest and variants of concern are assessed as such by the World Health Organisation (WHO) and for the EU by the European Centre for Disease Prevention and Control (ECDC) based on key properties of the virus such as transmission, severity and ability to escape immune response.

The European Centre for Disease Prevention and Control has assessed the B.1.617.2 variant first detected in India as a variant of interest and keeps this assessment under constant review. Variants of interest are variants that show increased transmissibility and severity. On 10 May 2021, the World Health Organization proposed to change the classification of the B.1.617.2 variant from “variant of interest” to “variant of concern”.

Under the current Council Recommendation on the temporary restriction on non-essential travel into the EU, member states can temporarily limit the categories of essential travellers that can travel to the EU where the epidemiological situation worsens quickly and where a high incidence of variants of concern of the virus is detected. 

The Council recommendation covers all member states (except Ireland), as well as the four non-EU states that have joined the Schengen area: Iceland, Liechtenstein, Norway and Switzerland. For the purpose of the travel restriction, these countries are covered in a similar way as the member states.

The latest information on the rules applying to entry from non-EU countries as communicated by member states are available on the Re-open EU website.

More information

Press release: Coronavirus: Commission proposes to ease restrictions on non-essential travel to the EU while addressing variants through new ‘emergency brake' mechanism, 3 May 2021

European Centre for Disease Prevention and Control threat assessment brief: Emergence of SARS-CoV-2 B.1.617 variants in India and situation in the EU/EEA, 11 May 2021

Travel during the coronavirus pandemic

Continue Reading

coronavirus

'I'm finally here': Greece formally opens to tourists

Reuters

Published

on

By

Tourists eat at the Monastiraki district, as the country's tourism season officially opens, in Athens, Greece May 15, 2021. REUTERS/Costas Baltas
Tourists visit the ancient temple of Hephaestus, as the country's tourism season officially opens, in Athens, Greece May 15, 2021. REUTERS/Costas Baltas

Greece formally opened to visitors on Saturday (15 May), kicking off a summer season it hopes will resurrect its vital tourism industry battered by the coronavirus pandemic.

After months of lockdown restrictions, Greece also opened its museums this week, including the Acropolis museum, home to renowned sculptures from Greek antiquity.

"I feel really alive and good because it has been such a hard and long year because of COVID," said Victoria Sanchez, a 22-year-old student on holiday from the Czech Republic.

"I feel again alive," she said, as she strolled near the Roman Agora in downtown Athens.

As of Saturday, foreign tourists will be allowed in Greece if they have been vaccinated or can show negative COVID-19 test results. Travel between regions, including to the islands, will also be allowed for those with negative tests or vaccinations.

"Greece is offering what people need," Tourism Minister Harry Theoharis tweeted. "Calm and care-free moments on the road towards normality."

Tourists in Athens were elated.

"I'm finally here," said Rebecca, a tourist in Athens from Florida, who declined to give her last name. "I've been waiting two years - two years with the COVID."

Greece has been rolling out vaccines to its islands and hopes to vaccinate most of them by the end of June. The government says vaccines and rapid testing, as well as warmer weather allowing outdoor activities, mean visitors can travel safely.

As the pandemic brought international travel to a halt in 2020, Greece suffered its worst year for tourism on record, with 7 million visitors compared with a record 33 million in 2019. Tourist revenues tumbled to 4 billion euros ($4.9 billion) from 18 billion euros.

This year, it is aiming for 40% of 2019 levels.

On the island of Mykonos, one flight was given a water salute upon landing. Four islands in the south Aegean, including Mykonos, received 32 international flights on Saturday from countries including Sweden, Germany and Qatar.

Corfu, in the Ionian sea, welcomed visitors from Germany and France.

"We are so happy. I'm happy to be here," said Pierre-Olivier Garcia, soon after arriving on the island.

Greeks also welcomed the lifting of lockdown measures, with scores of people leaving for the islands or holiday homes on the mainland on Saturday.

"The first weekend of freedom," Alpha TV proclaimed during a broadcast from the busy port of Piraeus.

Greece fared better than much of Europe during the first wave of the pandemic, but rising infections later in 2020 forced it to impose several lockdowns to protect its struggling health system.

A country of 11 million, it has recorded 373,881 infections and 11,322 deaths.

($1 = 0.8237 euros)

Continue Reading

coronavirus

Italian study shows COVID-19 infections, deaths plummeting after jabs

Reuters

Published

on

By

COVID-19 infections in adults of all ages fell by 80% five weeks after a first dose of Pfizer (PFE.N), Moderna (MRNA.O) or AstraZeneca (AZN.L) vaccine, according to Italian research published on Saturday (15 May).

The first such study by a European Union country on the real-world impact of its immunisation campaign was carried out by Italy's National Institute of Health (ISS) and the Ministry of Health on 13.7 million people vaccinated nationwide.

Scientists started studying data from the day Italy's vaccination campaign began, on Dec. 27 2020, until May 3 2021.

The analysis showed that the risk of SARS-CoV-2 infection, hospitalisation, and death decreased progressively after the first two weeks following the initial vaccination.

"As of 35 days after the first dose, there is an 80% reduction in infections, 90% reduction in hospitalisations, and 95% reduction in deaths," the ISS said, adding that the same pattern was seen in both men and women regardless of age.

"This data confirms the effectiveness of the vaccination campaign and the need to achieve high coverage across the population quickly to end the emergency," ISS president Silvio Brusaferro said in the statement.

Among the nearly 14 million people included in the Italian study, 95% of those who had taken Pfizer and Moderna had completed the vaccine cycle, while none of those given AstraZeneca had received a second dose.

Up until now, Italy has been following the makers' recommendations, giving a second dose of Pfizer three weeks after the first, a second dose of Moderna after a four week gap and a second dose of AstraZeneca after a 12 week gap.

As of Saturday morning, some 8.3 million Italians, or 14% of the population, were completely vaccinated, while around 10 million people had received a first jab.

Continue Reading

Twitter

Facebook

Trending