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J&J jab linked to more blood clots; double vaccine production, says UN – as it happened

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A nurse administers a Covid-19 vaccine Prayagraj, Uttar Pradesh.
A nurse administers a Covid-19 vaccine Prayagraj, Uttar Pradesh. Photograph: Prabhat Kumar Verma/ZUMA Wire/REX/Shutterstock
A nurse administers a Covid-19 vaccine Prayagraj, Uttar Pradesh. Photograph: Prabhat Kumar Verma/ZUMA Wire/REX/Shutterstock

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The European Union’s executive has called on countries of the bloc to temporarily halt non-essential travel from India to limit the spread of the Covid-19 variant.

The European Commission said its proposal followed the World Health Organisation’s proposal on Monday to reclassify the B.1.617.2 strain found in India as a “variant of concern”, raising the alert from a “variant of interest”.

EU countries should apply an “emergency brake” on non-essential travel from India, it said in a statement.

“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,” the Commission added.

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A UK holiday firm has temporarily stopped selling trips abroad for the summer in response to the government’s “traffic light” system for quarantine-free travel, PA reports.

On the Beach’s chief executive Simon Cooper said the system provides no clarity beyond a three-week window about which destinations people can travel to without isolating.

He said his firm had “no interest in selling holidays that are unlikely to happen” and would suspend sales for trips in June, July and August.

Under the so-called traffic light system, which has been adopted by England and Scotland, countries are divided into three categories - green, amber and red.

Travellers who visit a country on the green list when international travel resumes from May 17 will not have to quarantine upon their return.

United Nations secretary-general Antonio Guterres has highlighted the need to double the capacity of Covid-19 vaccine production, Reuters reports.
Speaking at a briefing with Russian foreign minister Sergei Lavrov after talks in Moscow, he also said Russia’s Sputnik V vaccine is able to address the pandemic challenges.

COVID-19 infected patients lie on ground of passage of a hospital at a government hospital in Kathmandu. Hospitals are overwhelmed with patients as cases continues to surge in Nepal. Photograph: Subash Shrestha/REX/Shutterstock

'Plausible causal association' between J&J jab and potentially life-threatening blood clotting

Here’s more on the snippet we posted earlier. The US Centers for Disease Control and Prevention has said it has found more cases of potentially life-threatening blood clotting among people who received the Johnson & Johnson Covid-19 vaccine and sees a “plausible causal association”.

Reuters has the story:

The CDC said in a presentation the agency has now identified 28 cases of thrombosis with thrombocytopenia syndrome (TTS) among the more than 8.7 million people who had received the J&J vaccine. TTS involves blood clots accompanied by a low level of platelets - the cells in the blood that help it to clot.

So far, three of the 28 have died. Previously, as of 25 April, the CDC had reported 17 cases of clotting among nearly 8 million people given vaccines.

The Advisory Committee on Immunization Practices or ACIP, which advises the CDC, recommended on 23 April that the US lift a 10-day pause on the J&J vaccinations imposed to review safety data on the clotting issue. The panel will review the new data later today.

The CDC said the events appear similar to what is being observed following administration of the AstraZeneca Covid-19 vaccine in Europe.

Both vaccines are based on a new technology using adenoviruses, which cause the common cold and have been modified to essentially render them harmless. The viruses are used to carry instructions into the body to make specific coronavirus proteins, priming the immune system to make antibodies that fight off the actual virus.

Scientists are working to find the potential mechanism that would explain the blood clots. A leading hypothesis appears to be that the vaccines are triggering a rare immune response that could be related to these viral vectors.

The syndrome does not appear to be associated with either of the vaccines produced by Pfizer and BioNTec, or Moderna.

And this just in ... The US should begin vaccinating adolescents with Pfizer-BioNTech Covid-19 jab, advisers to the Centers for Disease Control and Prevention (CDC) were told today, ahead of a vote awaited by states ready to start inoculating younger people.

Reuters reports:

The US Food and Drug Administration on Monday authorised the vaccine for children aged 12 to 15, offering relief to parents eager to get their children back to schools and summer camps.

The Advisory Committee on Immunization Practices (ACIP) provides recommendations to the CDC that many states will consider as they begin administering the two-shot vaccine to adolescents this week.

A working group concluded that benefits of the vaccine clearly outweigh risks and recommended the vaccine in a presentation to the meeting.

No one in the age group who received the vaccine in a clinical study got Covid-19, and there were no cases of Bell’s Palsy or severe allergic reactions, according to the working group presentation, which confirmed previous data.

Pfizer is running a separate trial testing the vaccine in children as young as 6-months-old, and has said it expects data on its use in 2- to 11-year-olds in September. The 2,260 participants in the 12-to-15 age group - half of whom were given placebo - were tested as an expansion of Pfizer’s more than 46,000-person trial.

Georgia yesterday became the latest US state, along with Delaware and Arkansas, to make Covid-19 vaccinations available to children as young as 12.

Reuters has the story:

Providers in these states are already offering Pfizer and BioNTech’s vaccine to those aged 12 to 15 – just a day after US regulators authorised it for emergency use in that age group.

A spokeswoman for Georgia’s public health agency said it chose to give shots right away to avoid turning young people away and risking them not coming back for the first jab of the two-shot regimen. Delaware also started early to meet demand for shots from young people and their parents, a spokeswoman said.

More than a dozen states surveyed by Reuters - including Texas, Idaho, Arizona, New York, Massachusetts, Illinois and Minnesota - said they would wait for the go-ahead from an advisory committee of the US Centers for Disease Control and Prevention (CDC) before they start administering the vaccine to children under 16.

On Monday, US president Joe Biden hailed the expanded FDA authorization as “a promising development in our fight against the virus.”

Most children with Covid-19 only develop mild symptoms or no symptoms at all, but can still spread the virus to vulnerable people. Parents may question the risks versus benefits, given the unknowns about the long-term effect of the vaccines on children’s development and their likelihood of being spared severe illness.

Australia has earmarked 25 million Covid vaccine doses from Moderna as it tries to speed up vaccinations of people under 50 after deciding against AstraZeneca, whose jab has been linked to rare blood clots.

Reuters reports:

The country had last month doubled its order for Pfizer-BioNTech’s vaccine to 40 million shots, preferring it over AstraZeneca for its nearly 12 million people in that age group.

Moderna said it will supply 10 million shots against the original strain of the virus this year and 15 million doses of its updated variant booster candidate in 2022.

Australia’s isolation strategy has helped it so far prevent a large pandemic impact, but its rollout of authorized vaccines from Pfizer-BioNTech and AstraZeneca has been slow. It has already walked back on its goal to vaccinate nearly all of its 26 million population by year end.

The prospect of Australia not achieving the objective until 2022 gained ground yesterday as its annual budget showed an expectation that its borders would not reopen until mid-2022, building pressure on Prime Minister Scott Morrison who faces an election in a year.

Australia’s supply deal with Moderna is subject to regulatory nod for the booster shot as well as its original vaccine candidate, which is authorised for emergency use in individuals above 18 years of age in the US.

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More clinical and real-world data is needed on how well and for how long Covid vaccines are protective before any decisions should be made on offering third or booster doses, Europe’s drug regulators have said.

Reuters reports:

The European Medicines Agency’s head of biological health threats and vaccines strategy Marco Cavaleri cautioned against making “premature” moves to deploy booster Covid-19 shots.

“We need to look into real-world evidence... to give us the data we need to know when would be the right time to give a third dose,” he said. “We need to have data that show in the field, either real-world evidence or clinical trials, that show what is the level of protection that is retained by the vaccines that we currently have.”

However, the EUn has already begun ordering Covid-19 booster vaccines and Britain and the United States have also begun preparing plans to offer third doses before the winter.

Asked about evidence so far on COVID-19 vaccine performance against a new variant that emerged in India, Cavaleri said EMA was monitoring the situation “very closely” and that data was “rather reassuring” for vaccines in use in the EU.

Sam Jones

Spain is aiming to welcome British tourists back without the need for a negative Covid test from 20 May, the country’s tourism minister has confirmed, as she urged overseas visitors to come and “enjoy a perfect holiday after the worst year of our lives”.

The minister, María Reyes, said two safety systems were in place to guarantee visitors’ health: the EU green digital certificate, which from June will show if the holder has been vaccinated, tested or recently recovered from Covid, and the forthcoming updating of EU recommendations on non-essential travel from countries outside the bloc.

The recommendations will be reviewed in the [EU] foreign affairs council on 20 May, and that will allow us to provide certainty to markets outside the European Union when it comes to the restarting of travel – especially travel from the UK, which is our largest market.

If all goes well, from 20 May – although there’s always a bit of the unknown over the evolution of the pandemic in the countries we’re focusing on with the campaign, though the numbers from the UK look good on both vaccination and accumulated incidence – Britons will be able to come to Spain. What’s more, they won’t be asked for a PCR test when they arrive in the country. I think it’s really good news.

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