Oxford COVID-19 vaccine trial set to recommence

Oxford COVID-19 vaccine trial set to recommence
Advanced trials of the coronavirus (COVID-19) vaccine developed by a team at Oxford University in partnership with pharmaceutical giant AstraZeneca are set to resume. (Reuters/File)
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Updated 10 September 2020

Oxford COVID-19 vaccine trial set to recommence

Oxford COVID-19 vaccine trial set to recommence
  • Patient suspected of developing transverse myelitis to be discharged after condition not diagnosed

LONDON: Advanced trials of the coronavirus (COVID-19) vaccine developed by a team at Oxford University in partnership with pharmaceutical giant AstraZeneca are set to resume after being halted over fears that subjects might suffer adverse side effects.

AstraZeneca stopped trials in the UK, US, South Africa and Brazil after a patient was hospitalized with suspected transverse myelitis (TM), an inflammatory condition affecting the spinal cord. However, the patient in question is set to be released from hospital after examinations suggested she did not have the condition.

The company’s CEO Pascal Soriot said the delay had been “temporary” and that a panel of experts would investigate the situation.

“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials ... in large clinical trials, illnesses will happen by chance and must be independently reviewed,” an AstraZeneca spokesperson said.

Pauses in drug and vaccine trials are not unusual, and this is the second time the Oxford vaccine has had to be delayed because of unexplained illness. In July, AstraZeneca confirmed, trials were temporarily set back after a patient was diagnosed with multiple sclerosis, in a development unrelated to the vaccine.

Early phases of the trial, including around 1,000 volunteers in the UK, have seen several side effects among subjects, including fatigue and headaches.

Robin Shattock, professor of mucosal infection and immunity at Imperial College London, said: “I think this is pretty normal — if it’s shown not to be related to the vaccine it will restart in a couple of days and it will be seen as a storm in a teacup. Even if associated with the vaccine they may be allowed to proceed but with caution.”

UK Health Secretary Matt Hancock told British radio station LBC: “This is a normal part of a vaccine development that, when you find a problem, the system is paused while you investigate that particular problem. What it underlines is that we won’t bring forward a vaccine unless it is safe, no matter how enthusiastic I am for a vaccine.”

The Oxford project had been considered the frontrunner in the global quest to discover a viable vaccine for COVID-19, but some analysts now say that the delay could hand the initiative to a rival team.

US biotech firm Moderna and German company Biontech, in partnership with the US drugmaker Pfizer, are among those developing vaccines that have also reached the advanced trial stage.

Analysts at JP Morgan Cazenove, the US stockbroker, said: “While it is true that a delay could increase Moderna’s and Biontech’s odds of winning the so-called ‘race to the COVID-19 vaccine finish line,’ we think this adds little fundamental value, as a vaccine’s ultimate clinical profile should trump any first-mover advantage in what we still anticipate to be a competitive market.”

Dr Siu Ping Lam, the director of vaccine licensing at the UK Medicines and Healthcare Products Regulatory Agency, said: “We are urgently reviewing all the information and actively engaging with the researchers to determine whether the trial should restart as quickly as possible. Vaccine safety is of paramount importance and we continually monitor the safety of vaccines to ensure that the benefits outweigh any potential risks.”

Soriot confirmed, meanwhile, that the trial subject suspected of developing TM, a woman from the UK, had been given the Oxford vaccine and not a placebo as part of the trial.

Ian Jones, professor of virology at the University of Reading, said: “It’s inflammation of nervous tissue which can be caused by a number of agents, one of which is viruses. The stoppage might be because the symptoms are plausibly linked to the vaccine, although it could be something else.”

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Blow to global vaccine drive as Pfizer delays deliveries

Blow to global vaccine drive as Pfizer delays deliveries
Updated 15 January 2021

Blow to global vaccine drive as Pfizer delays deliveries

Blow to global vaccine drive as Pfizer delays deliveries
  • Pfizer said the modifications at the Puurs factory were necessary in order to ramp up its production capacity from mid-February of the vaccine
  • There will be “a significant increase” in deliveries in late February and March, the US group promised

BERLIN: A global coronavirus vaccine rollout suffered a major blow Friday as Pfizer said it would delay shipments of the jabs in the next three to four weeks due to works at its key plant in Belgium.
Pfizer said the modifications at the Puurs factory were necessary in order to ramp up its production capacity from mid-February of the vaccine developed with Germany’s BioNTech.
There will be “a significant increase” in deliveries in late February and March, the US group promised. The European Commission also confirmed that promised doses for the first quarter will arrive within the period.
But European Union nations, which are desperately waiting for more doses to immunize their populations against the virus that has already claimed almost two million lives worldwide, expressed frustration.
Germany, the EU’s biggest economy, voiced regret over the “last minute and unexpected” delay.
It urged the European Commission — which undertook joint procurement for the bloc — to “seek clarity and certainty” for upcoming shipments.
Six northern EU nations also warned in a letter to the Commission that the “unacceptable” situation “decreases the credibility of the vaccination process.”
The letter signed by ministers from Denmark, Estonia, Finland, Latvia, Lithuania and Sweden further asked the Commission to “demand a public explanation of the situation” from the pharmaceutical companies.
Across the Atlantic, Canada also said it was impacted by the delays, calling it “unfortunate.”
“However, such delays and issues are to be expected when global supply chains are stretched well beyond their limits,” said Canada’s Procurement Minister Anita Anand.
Pfizer/BioNTech’s vaccine, which was developed at record-breaking speed, became the first to be approved for general use by a Western country on December 2 when Britain gave it the go ahead.
After Britain rolled out its immunization drive, the EU followed from December 27.
The latest shipment delay will likely add fuel to anger over the bloc’s vaccination campaign, which has already been criticized for being too slow compared to the United States or former EU member Britain.
The European Commission has also been accused of not securing enough doses early enough.
Just last week, the EU struck a deal to double its supply of the BioNTech/Pfizer vaccine to 600 million doses.
The urgency of immunizing the population has grown over fears of virus variants first seen in South Africa and Britain, which officials warn are more infectious.
But vaccine makers had repeatedly warned that production capacity was limited.
While Pfizer is augmenting capacity at Puurs, its partner BioNTech on Friday secured authorization to begin production at Germany’s Marburg.
The challenges of getting millions of vaccines around the world are also huge as the BioNTech/Pfizer jabs must be stored at ultra-low temperatures of about minus 70 degrees Celsius (-94 Fahrenheit) before being shipped to distribution centers in specially-designed cool boxes filled with dry ice.
Once out of ultra-cold storage, the vaccine must be kept at two Celsius to eight Celsius to remain effective for up to five days.