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Swedish health agency investigates after 1,000 people receive Moderna vaccine kept at too low a temperature - rt

Swedish health agency investigates after 1,000 people receive Moderna vaccine kept at too low a temperature

Around 1,000 Swedes have received Moderna Covid-19 shots that were kept too cold while being transported, the company in charge of deliveries, Apoteket AB, said on Friday.
rt - 37 minutes ago
Don

Don't Bring Your Gun to Work If You Happen to Be a Member of Congress

The House of Representatives's new metal detectors are getting a workout.
vice - 57 minutes ago
Hong Kong to enter city’s 1st Covid-19 lockdown, as China deploys 1,700 officers to enforce new rules - rt

Hong Kong to enter city’s 1st Covid-19 lockdown, as China deploys 1,700 officers to enforce new rules

Hong Kong has ordered thousands of residents to remain in their homes ahead of the city’s first Covid-19 lockdown, with China deploying 1,700 officers to enforce the restrictions in hopes of containing the outbreak.
rt - 1 hour ago
School ‘horrified’ after 400 celebrate wedding on premises despite lockdown - metro

School ‘horrified’ after 400 celebrate wedding on premises despite lockdown

The school hall had been rented out to an external organisation.
metro - 2 hours ago
Facebook Finally Admits Its ‘Pivot to Privacy’ Will Help Child Abusers - vice

Facebook Finally Admits Its ‘Pivot to Privacy’ Will Help Child Abusers

Facebook currently accounts for 94% of all online child abuse reports.
vice - 2 hours ago
Getting Parler Back Online Is Not Going Great - vice

Getting Parler Back Online Is Not Going Great

A federal judge just dismissed Parler's attempt to make Amazon Web Services take it back.
vice - 2 hours ago
No homemade face coverings: German airlines mandating passengers to wear higher grade FFP2 or N95 masks - rt

No homemade face coverings: German airlines mandating passengers to wear higher grade FFP2 or N95 masks

Passengers will be mandated to wear higher-grade masks against Covid-19 when flying German airlines and their subsidiaries, starting next month. Tougher mask rules have also been introduced in malls and on public transport.
rt - 2 hours ago
£76,000,000 worth of cocaine found in shipment of bananas in UK port - metro

£76,000,000 worth of cocaine found in shipment of bananas in UK port

Border Force officers seized nearly a tonne of cocaine at the Port of Southampton.
metro - 3 hours ago
EU says it will seek

EU says it will seek 'clarification' from Pfizer after further Covid-19 vaccine delays

The European Union has said further contact is needed with Pfizer after it was reported that the pharmaceutical giant will be reducing deliveries for the second week running as the company upgrades its manufacturing plant.
rt - 3 hours ago
Iranian minister boasts about significant rise in oil exports despite US sanctions - rt

Iranian minister boasts about significant rise in oil exports despite US sanctions

Iran’s petroleum minister has bragged about the country’s rising oil exports in the face of US sanctions, as the nation claims that its international petroleum sales have hit record highs.
rt - 3 hours ago
York Uni pulls image of three wise monkeys it deemed ‘racist’ - metro

York Uni pulls image of three wise monkeys it deemed ‘racist’

Academics thought the symbol was offensive in the context of a call for research 'that represented black, indigenous and people of colour'.
metro - 4 hours ago
More than 1,000,000 people had Covid last week - metro

More than 1,000,000 people had Covid last week

One in 35 people had the deadly disease in London, amounting to 300,000 infections.
metro - 4 hours ago
£20 pulse oximeter gadget could save lives from Covid-19 - metro

£20 pulse oximeter gadget could save lives from Covid-19

The home gadgets clip to the fingertip and measure the percentage of oxygen in the blood
metro - 4 hours ago
Chinese authorities find Covid-19 cluster at major chicken processing plant in Harbin as Beijing introduces new curbs - rt

Chinese authorities find Covid-19 cluster at major chicken processing plant in Harbin as Beijing introduces new curbs

A new cluster of Covid-19 has been detected in Harbin, in northeast China’s Heilongjiang Province, with authorities registering 10 symptomatic Covid-19 cases and 31 asymptomatic infections.
rt - 4 hours ago
Modi praises India’s ‘self-reliance’ in Covid-19 vaccine production as the country administers millionth jab - rt

Modi praises India’s ‘self-reliance’ in Covid-19 vaccine production as the country administers millionth jab

The Indian prime minister has talked up his country’s capacity to overcome the coronavirus pandemic using indigenous vaccines and those manufactured in the world’s second most populous nation.
rt - 5 hours ago
Series 6, Episode 23: Russell T Davies - channel 4

Series 6, Episode 23: Russell T Davies

Russell talks to Krishnan about how he believes the impact of coronavirus will transpire in dramas and plays for years to come and his view on whether gay roles should only be played by gay actors.
channel 4 - 5 hours ago
Hungary to build plant for manufacturing own vaccine, says PM Orban, after criticizing EU immunization program - rt

Hungary to build plant for manufacturing own vaccine, says PM Orban, after criticizing EU immunization program

Hungarian Prime Minister Viktor Orban has said the country needs a new facility to ensure steady domestic vaccine production and to manufacture its own Covid-19 jab.
rt - 6 hours ago
Poland threatens Pfizer with legal action after Covid-19 vaccine delay as Italy’s government backs action against the pharma giant - rt

Poland threatens Pfizer with legal action after Covid-19 vaccine delay as Italy’s government backs action against the pharma giant

The Polish government has warned it will take legal action against drugmaker Pfizer, after the company only delivered half the expected doses of Covid-19 vaccine this week, jeopardizing the country’s inoculation program.
rt - 6 hours ago
Was Donald Trump destined to join the one-term president club? - channel 4

Was Donald Trump destined to join the one-term president club?

Donald Trump has become something he never wanted to be: a loser. He joins a list of US presidents who asked the American people for another chance, another term - and failed.
channel 4 - 10 hours ago
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channel 4
FactCheck Q&A: how safe is the Oxford Covid-19 vaccine? 

FactCheck Q&A: how safe is the Oxford Covid-19 vaccine? 

channel 4 - 1 month ago

There was more apparent good news this week on the race to develop a vaccine against the coronavirus.

The drug company AstraZeneca said in a press release that its AZD1222 vaccine candidate had proved to be “highly effective” in preventing Covid-19, based on early results from clinical trials in the UK and Brazil.

The vaccine is being developed in collaboration with scientists at Oxford University, with financial backing from the UK government.

The results were widely reported as good news. But the headline figures for how many infections the vaccine prevented were slightly lower and harder to understand than other vaccines that have recently reported trial results.

Now the Oxford vaccine has been criticised by some in the scientific community for offering incomplete and confusing data, and only belatedly admitting to an error that changed the results.

Some scientists have even said that they doubt whether the British vaccine would be approved by regulators in the US.

Let’s try to put all this in context.

Why is the Oxford/AstraZeneca vaccine under fire?

AstraZeneca put out a press release saying its vaccine prevented up to 90 per cent of Covid-19 infections, depending on how much vaccine people were given.

This was a less clear-cut result than those offered by Pfizer and Moderna, who are also developing vaccines and claim 95 per cent efficacy – a calculation based on new coronavirus infections among people vaccinated, compared to those given a placebo.

In the Oxford clinical trials, two full doses given a month apart prevented 62 per cent of cases. When they halved the first dose, efficacy rose to 90 per cent. Averaging the two gave an overall efficacy of 70 per cent.

While the team are looking at data from more than 23,000 participants in total, only 2,741 people got the dose that protected against 90 per cent of infections.

Some scientists, like former senior Pfizer executive John LaMattina, have said they doubt whether US regulators would grant emergency use authorization to AstraZeneca on the bases of such a small number, saying: “More data for this dosing (regimen) will be needed.”

Dosing error

There’s a second issue: AstraZeneca only admitted after it had published the initial press release that the difference in dosage given to different groups of trial participants stemmed from an error in the manufacturing process.

Mene Pangalos, head of drug research at AstraZeneca, played down the mistake, calling it “serendipity.”

A spokesman for the Oxford researchers said the team spotted the error and raised it with regulators.

They agreed that the scientists could test both the lower and higher dose groups and include the results on the phase III trial.

The researchers say the dosing problem has been fixed now, but they say they don’t yet know why giving people a lower first dose proved, apparently, to be more effective.

What do independent experts say?

Dr Joy Leahy, Royal Statistical Society Statistical Ambassador, told the Science Media Centre: “The dosing error does throw up some problems.

Taking any trial, the more different dosing regimens that are in the trial, the more likely it is that any one regimen will turn out to have a particularly high efficacy, just because of chance and random variation.”

The scientist Hilda Bastian has been particularly critical of AstraZenecas approach, writing in Wired that its results come from “patched-together analysis instead of data from a single, large trial” like Pfizer and Moderna.

Others have defended the Oxford team’s approach, pointing out that regulators approved the decision to include the lower dose group in the trial and that efficacy in the high dose group was still above 50 per cent – often considered the bar for a successful vaccine.

Most scientists say they are suspending judgement until the full peer-reviewed results are published.

With only the scant details of a short press release to go on, there are many unanswered questions about the data.

Why don’t we have the full data yet?

There’s long been criticism of the way drug companies announce selective results from trials in press releases, instead of publishing the full data in peer-reviewed journals.

The incomplete information often leaves scientists scratching their heads over how to interpret the data. Issuing press releases ahead of a proper data release is, however, standard practice.

Professor Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said in a statement: When the trial data indicate that the vaccine is likely to meet the criteria for authorization of use then they have to inform the investigators and the companies.

At that stage because there could be leaks of confidential information which might result in insider trading, the sponsors and investigators have to put out a press release with minimal information because of stock market law.

This of course is not ideal from a scientific point of view but has become necessary in this pandemic.

He added: “The way the data are put together will have been specified in the protocol and scrutinised very carefully by regulators to ensure that there is no cherry picking of the results.

We have good grounds for trusting that the regulation in this high-profile area will be done as carefully or more carefully for these vaccines than for any others in the past.”

sauce: channel 4
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