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AstraZeneca US trials thrown into doubt after promising data

Agence France-Presse
AstraZeneca US trials thrown into doubt after promising data
(FILES) In this file photo a nurse picks up a bottle of the AstraZeneca Covid-19 vaccine during a mass vaccination campaign for people between ages of 50 to 55 in Vigo, northwestern Spain, on March 13, 2021. A US health agency raised concerns on March 23, 2021 that AstraZeneca may have included out-of-date information during trials of its Covid-19 vaccine, the day after the company said its drug was highly effective in preventing the disease. The news comes as Europe continues to wrangle over supplies of the jab, and after weeks of uncertainty centred on fears it was linked to an increased risk of blood clots.
AFP / Miguel Riopa

WASHINGTON, United States — A US health agency raised concerns Tuesday that AstraZeneca may have included out-of-date information during trials of its Covid-19 vaccine, a day after the company said its drug was highly effective in preventing the disease.

The Anglo-Swedish pharma giant stood by its assessment of the results of its US trials, saying it would publish new data "within 48 hours" in response to concerns raised by the US National Institute for Allergies and Infectious Diseases. 

In more bad publicity for AstraZeneca, French authorities said they are investigating the death of a 26-year-old medical student days after he received their Covid-19 vaccine, while stressing that no link had been established yet with the jab.

The fresh problems for the drugmaker, which had on Monday hailed its vaccine as 79 percent effective at preventing Covid-19, come as Europe continues to wrangle over shortages of the jab and after weeks of safety concerns. 

With AstraZeneca delivering only 30 percent of the doses it promised the EU for the first quarter, Germany threw its weight behind a ban on European exports of the jab, while also announcing strict virus measures over Easter to contain spiralling infections. 

The European Commission will on Wednesday adopt "a revision of the export transparency and authorisation mechanism," a spokesman in Brussels told journalists.

Meanwhile, Britain marked the anniversary of its first coronavirus lockdown by holding a minute's silence for the more than 126,000 of its citizens who have died from Covid-19, the fifth-highest death toll in the world.

The global death toll now stands at more than 2.7 million.

Putin gets jabbed

Russian President Vladimir Putin on Tuesday received his first dose of a coronavirus vaccine, his spokesman said as Russia looks to boost a vaccination campaign that is faltering despite having produced three home-grown jabs.

Putin thus joined other world leaders who have received jabs including US President Joe Biden, Pope Francis and Britain's Queen Elizabeth.

But unlike many others who were vaccinated in public, Putin's vaccination took place in private and Kremlin spokesman Dmitry Peskov did not specify which jab was administered.

AstraZeneca's vaccine had been hailed as a potential game-changer in the fight against the pandemic as it is cheaper and easier to store and transport than many of its rivals, making it more accessible for poorer nations. 

But public confidence in the drug has tumbled after more than a dozen countries temporarily suspended its rollout because of isolated cases of blood clots in people who had received a dose. 

The EU's medicines regulator and the World Health Organization insist there is no evidence linking the vaccine to blood clots.

Scant supplies of AstraZeneca doses in Europe have meanwhile hampered the continent's vaccine rollouts, which lag far behind countries like the UK and Israel.  

French President Emmanuel Macron said Tuesday that his country should be giving vaccines "morning, noon and evening", as his government announced that 35 new mass inoculation centres would open soon.    

"We're going to change pace from April," he said, adding that there should be "no weekend and days off when it comes to vaccinations".

'Much deadlier'

In Germany, Merkel ordered a nationwide shutdown for five days between April 1 and April 5 as Christians celebrate Easter, with almost all shops closed and religious services moved online.

A variant first identified in Britain has become the dominant strain circulating in Germany, she said, adding: "We are in a new pandemic."

"Essentially, we have a new virus... it is much deadlier, much more infectious and infectious for much longer."

The Netherlands announced it is extending its coronavirus restrictions until April 20 as cases are rising.

Ukraine said it too was battling a new wave of infections as it reported the highest death toll since the beginning of the crisis, with 300 fatalities in the past 24 hours.  

And in Slovakia, liberal President Zuzana Caputova demanded the resignation of centrist Premier Igor Matovic as the country struggles with one of the world's highest Covid-19 death rates.

Banksy fundraiser

In tribute to its Covid dead, Britain held a "National Day of Reflection" on Tuesday, with parliament holding a minute's silence and bells ringing out across the country. 

The country's state-run National Health Service (NHS) has been under huge strain, and on Tuesday a painting by UK street artist Banksy sold for a record £16.75 million ($23.1 million, 19.4 million euros) in an auction by Christie's to raise money for health workers.

The artist left a note with the piece thanking hospital staff for their work battling the pandemic.

"Thanks for all you're doing. I hope this brightens up the place a bit, even if it's only in black and white," he wrote.

ASTRAZENECA

COVID-19 VACCINE

NOVEL CORONAVIRUS

UNITED STATES

As It Happens
LATEST UPDATE: April 14, 2022 - 9:19am

Pharma giants Sanofi and GSK said on July 29, 2020, that they have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine. The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract."

This thread collects some of the major developments in the search for a vaccine to ease the new coronavirus pandemic. (Main photo by AFP/Joel Saget)

April 14, 2022 - 9:19am

The head of US pharmaceutical giant Pfizer says a COVID-19 vaccine effective against multiple variants is possible before the end of 2022.

Chairman Albert Bourla says the firm was also working on producing a vaccine that could provide good protection for a whole year, meaning people would come back annually for boosters, as with influenza shots.

"I hope, clearly by autumn... that we could have a vaccine" that worked against not only the dominant Omicron but all known variants, he says. — AFP 

March 25, 2022 - 2:16pm

Australia is offering a fourth dose of COVID-19 vaccines to over 65s from next month, federal health authorities announce, as a new Omicron strain races through the population.

The top advisory group on vaccines approved the fourth shot for vulnerable groups: those aged over 65, indigenous people over 50, people who are immunocompromised and care home residents.

In the past six weeks, other countries, including France, Germany and Sweden as well as  health authorities in England, have recommended a fourth Covid-19 vaccine dose for the most vulnerable, including the elderly. — AFP

March 18, 2022 - 10:13am

Moderna announces it had asked the United States drug regulator for emergency authorization for a second booster shot of the company's COVID-19 vaccine for all adults.

The request to the US Food and Drug Administration (FDA) would "allow for a fourth dose of our #COVID19 vaccine in adults 18 years of age and older who have received an initial booster" of any approved Covid jab, Moderna said on Twitter.

The request comes days after Pfizer-BioNTech, makers of the other Covid mRNA vaccine, also requested emergency approval for a second booster shot, but their request was limited to adults aged 65 and older. — AFP

March 18, 2022 - 10:12am

Moderna announces it had asked the United States drug regulator for emergency authorization for a second booster shot of the company's Covid-19 vaccine for all adults.

The request to the US Food and Drug Administration (FDA) would "allow for a fourth dose of our #COVID19 vaccine in adults 18 years of age and older who have received an initial booster" of any approved Covid jab, Moderna says on Twitter.

The request comes days after Pfizer-BioNTech, makers of the other Covid mRNA vaccine, also requested emergency approval for a second booster shot, but their request was limited to adults aged 65 and older. — AFP

March 17, 2022 - 2:34pm

The United States has given more than 500 million coronavirus vaccines to other countries since the jabs were developed, Secretary of State Antony Blinken said Thursday in a statement obtained by AFP.

"The United States has now shared over 500 million safe and effective Covid-19 vaccine doses, free of cost, to more than 110 countries and economies around the world — for the sole purpose of saving lives," Blinken said.

Washington aims to more than double that amount to 1.1 billion doses, as the Covid pandemic persists around the globe. — AFP

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