The Oxford/AstraZeneca shot has been plagued with questions about its most effective dosage since data showed some surprising results(AP)
The Oxford/AstraZeneca shot has been plagued with questions about its most effective dosage since data showed some surprising results(AP)

EU drug watchdog looking at timing of dosage in AstraZeneca-Oxford vaccine review

For the European Medicines Authority, the crucial point is the level of protection people have once they have received the first shot and then have to wait between four and 12 weeks for the second one. In a statement, the EMA said it expected more information from ongoing trials in January.
By Reuters | Posted by Ayshee Bhaduri | London
PUBLISHED ON DEC 31, 2020 02:20 PM IST

The European Union (EU) drug watchdog is looking at when people should be given the second dose of AstraZeneca and Oxford University’s Covid-19 vaccine, rather than at the size of the first dose, as part of its review of the shot, a source at the agency said on Wednesday.

Britain on Wednesday became the first country in the world to approve the coronavirus vaccine developed by the British duo, with the authorities recommending that a second shot is administered between four and 12 weeks after the first.

Two full doses three months apart were found to be 80% efficacious, the UK drug regulator said, higher than the average that the developers themselves had found in their late-stage trials.

For the European Medicines Authority (EMA), the crucial point is the level of protection people have once they have received the first shot and then have to wait between four and 12 weeks for the second one, the source said.

“This is exactly what we are looking at. You must have sufficient coverage with the first dose given that this is a vaccination campaign in the middle of a pandemic,” the source, who declined to be named due to the sensitivity of the matter, said.

Earlier on Wednesday, AstraZeneca said it had submitted full data to pursue conditional marketing authorisation from the EMA, but the regulator said it still needs more information for approval.

In a statement, the EMA said it expected more information from ongoing trials in January and it has requested additional scientific data from the company. It did not respond to Reuters’ request for comment on its analysis of timing and dosages.

The Oxford/AstraZeneca shot has been plagued with questions about its most effective dosage since data showed some surprising results.

Two full doses were given to the majority of participants and were shown to be 62% efficacious - but a smaller group of volunteers received by accident half a dose followed by a full dose, and registered 90% efficacy.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) said on Wednesday that the 90% rate had not stood up to analysis.

The issue of the first shot at half dosage is also not on the table at EMA, with the regulator only looking at the two full dosage regimen.

It makes more sense for the timing of the second shot to affect efficacy rather than the dosage size in this case, the source at EMA said.

“The 12-week thing is reassuring from a scientific point of view because there is a logical explanation for these types of vaccines, but that the half dose was more effective than the full dose is something that actually clashes with logic,” the source said.

However, the source said the variations in the trial have caused a complexity that makes it more difficult for regulators to assess it.

AstraZeneca’s late-stage trial was originally designed for two injections four weeks apart. But in late-stage trial data published in The Lancet medical journal on December 12., the company said most participants had delays in receiving their second shot.

The median time between two standard doses in UK volunteers was about 10 weeks, and six weeks in Brazil, it said.

“Some people received the dose four weeks later, others 12 weeks later. It was all very variable. And that’s why it’s very difficult to interpret these studies,” the EMA source said.

SHARE THIS ARTICLE ON
Close
Lou Jiwei, chairman of the National Council for Social Security Fund (NCSSF), speaks at the China Development Forum in Beijing, China in this file photo from 2018. (REUTERS)
Lou Jiwei, chairman of the National Council for Social Security Fund (NCSSF), speaks at the China Development Forum in Beijing, China in this file photo from 2018. (REUTERS)

China's ex-finance minister says nation's fiscal situation 'extremely severe'

ANI, Beijing
PUBLISHED ON MAR 02, 2021 08:31 PM IST
Lou offered his sharp critique in December but the assessment has only been made public more recently, with just days to go before China's political elites meet for their annual legislative session.
Close
The army seized power after its allegations of fraud in Nov. 8 elections were rejected.. (AP Photo)(AP)
The army seized power after its allegations of fraud in Nov. 8 elections were rejected.. (AP Photo)(AP)

Doctors, teachers, a fortune-teller amongst Myanmar's new wave of detainees

Reuters
PUBLISHED ON MAR 02, 2021 08:24 PM IST
  • Some detainees are survivors of prison under the former junta. Some were taken from their homes, hundreds were seized by riot police and soldiers who charged down protests against the coup
Close
Vernon Jordan arrives at the Metropolitan Museum of Art in New York for the kickoff of former US President Bill Clinton's memoirs.(REUTERS / File Photo)
Vernon Jordan arrives at the Metropolitan Museum of Art in New York for the kickoff of former US President Bill Clinton's memoirs.(REUTERS / File Photo)

US rights activist, former Clinton advisor Vernon Jordan dies at 85: Report

Posted by Kunal Gaurav | Reuters, Washington
PUBLISHED ON MAR 02, 2021 08:13 PM IST
Jordan's role as a Washington insider took him all the way to the White House, where he was a close friend and adviser to President Bill Clinton in the 1990s.
Close
US President Joe Biden called the jailing of Navalny “politically motivated.”(Bloomberg)
US President Joe Biden called the jailing of Navalny “politically motivated.”(Bloomberg)

US announces sanctions on Russian officials, businesses for Navalny's poisoning

Posted by Kunal Gaurav | Bloomberg
PUBLISHED ON MAR 02, 2021 07:42 PM IST
  • The sanctions are the first ordered by President Joe Biden against Russia and will help set the tone for his relations with Putin.
Close
Pakistani Taliban patrol in their stronghold of Shawal in Pakistani tribal region of South Waziristan in this file photo in this file photo from 2012. (AP Photo)
Pakistani Taliban patrol in their stronghold of Shawal in Pakistani tribal region of South Waziristan in this file photo in this file photo from 2012. (AP Photo)

Taliban collecting funds openly, Pak govt turning blind eye: PTM leader Afridi

ANI, Islamabad
UPDATED ON MAR 02, 2021 08:22 PM IST
Afridi said, "Whenever there are important meetings of important organisations like the United Nations and FATF, these terrorists and terrorist organisations are banned but the moment these meetings are finished, they resurface".
Close
The Merck logo is seen at a gate to the Merck & Co campus in Linden, New Jersey, US.(REUTERS)
The Merck logo is seen at a gate to the Merck & Co campus in Linden, New Jersey, US.(REUTERS)

Merck to help make Johnson & Johnson's single-shot Covid-19 vaccine: Report

Posted by Kunal Gaurav | Reuters
PUBLISHED ON MAR 02, 2021 07:29 PM IST
US-based Merck halted the development of two of its own coronavirus vaccines in January to instead focus on its two Covid-19 treatments.
Close
Sri Lanka announced on Tuesday that it would develop another terminal — West Container Terminal — at the same port with India and Japan.(Reuters | Representational image)
Sri Lanka announced on Tuesday that it would develop another terminal — West Container Terminal — at the same port with India and Japan.(Reuters | Representational image)

Sri Lanka approves new port development with India and Japan

AP, Colombo
PUBLISHED ON MAR 02, 2021 07:15 PM IST
Sri Lanka halted the 2019 agreement for India and Japan to develop and operate the crucial East Container Terminal at Colombo Port after weeks of protests by trade unions and opposition parties.
Close
A German police staff member receives AstraZeneca's vaccine against the coronavirus disease (Covid-19), in Munich, Germany.(REUTERS)
A German police staff member receives AstraZeneca's vaccine against the coronavirus disease (Covid-19), in Munich, Germany.(REUTERS)

Covid-19: Which countries have most number of fully vaccinated people?

By hindustantimes.com | Edited by Kunal Gaurav, New Delhi
PUBLISHED ON MAR 02, 2021 07:08 PM IST
  • The number of fully vaccinated people are nowhere near the number of doses administered since most of the countries are using Covid-19 vaccines that require a two-doses regimen.
Close
Since January 2020, Austria has had a coalition government under center-right Chancellor Sebastian Kurz that includes the environmentalist Green party, which oversees the powerful climate, environment and energy ministry.(Pixabay/ Representational Photo)
Since January 2020, Austria has had a coalition government under center-right Chancellor Sebastian Kurz that includes the environmentalist Green party, which oversees the powerful climate, environment and energy ministry.(Pixabay/ Representational Photo)

Multiple sclerosis patient sues Austria over health impact of climate change

AP
PUBLISHED ON MAR 02, 2021 07:06 PM IST
  • The case being filed next month before the European Court of Human Rights is supported by the environmental group Fridays for Future, which is helping to crowdfund the legal costs.
Close
Saudi Crown Prince Mohammed Bin Salman(Reuters)
Saudi Crown Prince Mohammed Bin Salman(Reuters)

Media watchdog seeks German investigation of Saudi crown prince over Khashoggi

Reuters
PUBLISHED ON MAR 02, 2021 07:00 PM IST
Prince Mohammed has denied any involvement in Khashoggi's killing. Other Saudi figures named in the RSF filing could not be reached for comment and the Saudi government's media office did not immediately respond to a request for comment.
Close
A patient waits at a coronavirus disease vaccination center installed inside a gymnasium in Taverny near Paris.(Reuters)
A patient waits at a coronavirus disease vaccination center installed inside a gymnasium in Taverny near Paris.(Reuters)

On the Covid-19 frontline, half of French care home workers don't trust vaccine

Reuters
PUBLISHED ON MAR 02, 2021 06:19 PM IST
One reason for the scepticism is that those recommending the vaccine are the same people - the French state - whom care home workers blame for their low pay and tough working conditions, said Malika Belarbi, a care worker and trade union official.
Close
A screenshot from the video telecast by state media showing the confession of a blogger, identified as Qiu, arrested for allegedly insulting PLA soldiers online. (CCTV/SCREENGRAB)
A screenshot from the video telecast by state media showing the confession of a blogger, identified as Qiu, arrested for allegedly insulting PLA soldiers online. (CCTV/SCREENGRAB)

China airs video confession of blogger booked for insulting PLA soldiers

By Sutirtho Patranobis I Edited by Sanya Mathur
PUBLISHED ON MAR 02, 2021 06:11 PM IST
In the one-minute long video played during a prime time news programme, the 38-year-old man, identified as Qiu, admitted to “annihilation of conscience” and “arrogance” for insulting PLA soldiers involved in the deadly brawl against the Indian army at Galwan Valley in eastern Ladakh last June
Close
Lebanon has been hammered by one crisis after another, starting with the outbreak of anti-government protests against the country’s corrupt political class in October 2019. That has been compounded by the coronavirus pandemic and a massive, deadly blast in Beirut’s port last August. (Representative Image)(AFP)
Lebanon has been hammered by one crisis after another, starting with the outbreak of anti-government protests against the country’s corrupt political class in October 2019. That has been compounded by the coronavirus pandemic and a massive, deadly blast in Beirut’s port last August. (Representative Image)(AFP)

Lebanese currency hits record low amid country's worsening crisis

AP
PUBLISHED ON MAR 02, 2021 05:39 PM IST
The dollar was trading at 9,975 Lebanese pounds around noon Tuesday. The previous record was registered in July, when the dollar briefly sold for 9,900 pounds on the black market. The official price remains 1,520 pounds to the dollar.
Close
Mikhail Gorbachev's legacy has also been partially unpicked in recent years as Moscow and Washington's ties have retreated to post-Cold War lows(AFP)
Mikhail Gorbachev's legacy has also been partially unpicked in recent years as Moscow and Washington's ties have retreated to post-Cold War lows(AFP)

Mikhail Gorbachev, last Soviet leader, to mark 90th birthday on Zoom

Reuters, Moscow
PUBLISHED ON MAR 02, 2021 05:37 PM IST
Gorbachev, who championed arms control and democracy-oriented reforms as Soviet leader in the 1980s, is widely credited with helping end the Cold War.
Close
Dananeer Mobeen, 19, a social media influencer who has become famous after her five-second video went viral.(Reuters)
Dananeer Mobeen, 19, a social media influencer who has become famous after her five-second video went viral.(Reuters)

'Pawri' power: 5-second social media clip pulls India, Pakistan closer

Reuters
PUBLISHED ON MAR 02, 2021 05:26 PM IST
  • The short video shot by Dananeer Mobeen in the Nathaigali mountains of northern Pakistan and uploaded onto Instagram shows a group of youngsters enjoying themselves by a roadside.
Close
SHARE
Story Saved
OPEN APP