Tag Archives: global trials

Q&A: Where are we in the COVID-19 vaccine race?

By Carl O’Donnell

NEW YORK (Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

As some companies close in on unveiling their initial findings – with Canadian and European regulators already reviewing early data on some vaccines – the following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives:

Who is furthest along?

U.S. drugmaker Pfizer Inc with German partner BioNTech SE, U.S. biotech Moderna Inc and Britain-based AstraZeneca Plc in conjunction with University of Oxford researchers could provide early analyses of data from their various large trials as early as October or November. Johnson & Johnson is a bit further behind.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot. Neither trial participants nor researchers know who has received the vaccine or placebo until the data is ready for review, or unblinded. The studies rely on subjects becoming naturally infected with COVID-19, so how long it takes to generate results largely depends on how pervasive the virus is where the trials are being conducted. In areas with large outbreaks and community spread, infections will pile up faster.

How will we know if the vaccine works?

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Vaccines must demonstrate at least 50% efficacy – meaning at least twice as many infections among volunteers who got a placebo as among those in the vaccine group. Independent panels oversee the trials to monitor for safety and effectiveness since the data is hidden from companies and researchers. These data safety monitoring boards take a peek at the interim results at pre-determined milestones, such as after a certain number of people have become infected. If the vaccine is looking significantly better than the placebo, the companies can apply for emergency use, and the study may be halted or continue to its intended conclusion. A trial can also be halted if the panel determines the vaccine to be unsafe.

Will regulators ensure a vaccine is safe before making it available to the public?

The U.S. Food and Drug Administration has said it will not approve a vaccine unless it is both effective and safe. Earlier this month, it added more stringent safety guidelines for U.S. vaccines. The FDA wants developers to follow trial subjects for at least two months after they receive their final vaccine dose to check for any side effects that may crop up. The agency will consider an emergency use authorization (EUA) once that data is collected from at least half of the trial’s participants. The UK Medicines and Healthcare products Regulatory Agency will review the vaccines for the UK and the European Medicines Agency will review vaccines for European Union use.

When will regulators decide?

Regulators will review the vaccines after the companies have enough data to submit applications seeking an EUA or formal approval. Moderna’s first look at data is more likely to come next month. AstraZeneca could provide a look at late-stage data in November. Pfizer/BioNtech said it may have data as early as October, but that it would wait for safety data it expects in the third week of November to file with U.S. regulators.

Regulators for Europe and Canada are considering data on a rolling basis, as it becomes available. The UK and the United States both expect speedy reviews of initial data for possible emergency use before more traditional lengthy reviews for formal commercial approvals.

Could these be the first approved coronavirus vaccines?

Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far along including from China National Biotec Group [CHNAPF.UL] (CNBG), CanSino Biologics <6185.HK> and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November. Russia’s Gamaleya Institute has begun a 40,000-person late-stage trial and is expected to have early data at the end of October or early November. Russia has also given the vaccine to at least hundreds of “high-risk” members of the general population.

Is U.S. authorization up to President Trump?

The FDA must make sure that the benefits of a vaccine outweigh the risks before authorization since they are intended to be given to hundreds of millions of healthy people. However, the U.S. Department of Health and Human Services (HHS) has the authority to override the FDA’s recommendation. President Donald Trump has complained about the new safety guidelines, which delay any vaccine availability until after the Nov. 3 presidential election at the earliest. The Trump administration can hire and fire HHS officials, opening the possibility of political pressure to approve a vaccine.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanovo in Moscow; Editing by Caroline Humer, Bill Berkrot and Frances Kerry)

AstraZeneca pauses coronavirus vaccine trial

LONDON (Reuters) – AstraZeneca has suspended global trials of its experimental coronavirus vaccine after an unexplained illness in a participant, knocking the British drugmaker’s shares on Wednesday as prospects for an early rollout dimmed.

The vaccine to combat COVID-19, which AstraZeneca is developing with the University of Oxford, has been described by the World Health Organization as probably the world’s leading candidate and the furthest developed.

However, AstraZeneca said on Tuesday it had paused trials, including late-stage ones, to allow an independent committee to review safety data, and it was working to minimize any potential impact on the timeline.

“It is obviously a challenge to this particular vaccine trial,” Britain’s Health Secretary Matt Hancock told Sky News.

The stakes are high because AstraZeneca, Britain’s largest drugmaker by market value, has already agreed to supply close to three billion doses to governments across the globe.

This is more than any other vaccine project, but asked whether the pause would set back the development process, Britain’s Hancock said: “Not necessarily, it depends on what they find when they do the investigation”.

Most states will contribute financially to developing the vaccine, even if the trial fails.

‘ROUTINE ACTION’

Britain’s medical regulator said it is urgently reviewing information available to determine whether trials can restart as quickly as possible.

A New York Times report citing a person familiar with the situation said a participant based in Britain was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.

Whether this was directly linked to AstraZeneca’s vaccine remains unclear, it said. AstraZeneca declined to comment.

A person familiar with the situation told Reuters the illness occurred in the British trial which began in May with more than 12,000 participants, from 5 years old to beyond 70.

The U.S. trial, with a targeted 30,000 participants, was launched last week for the vaccine AZD1222, which is also in late-stage clinical trials in Brazil and South Africa.

Additional trials are planned in Japan and Russia, with a targeted 50,000 participants globally.

South Korea said it would look into the suspension and review its plan to participate in manufacturing the vaccine and health ministry official Yoon Tae-ho added such suspensions of clinical trials were not rare “as various factors interact”.

This was echoed by Germany’s Leukocare, which is working on a vaccine similar to AstraZeneca’s but is at an earlier stage.

“When you are inoculating 20,000 people, it is a foregone conclusion that at some point you will have severe adverse events. As soon as a link to the vaccine can clearly be ruled out, the trial continues,” CEO Michael Scholl said.

Immune related conditions such as inflammations, however, would be subject to particular scrutiny, he added.

The Oxford vaccine is designed to instruct human cells to make distinguishing parts of the coronavirus. That allows the immune system to build an arsenal against future infections.

A harmless virus known as adenovirus is used to bring the genetic instruction into the body, an approach which is also being pursued by China’s CanSino, Russia’s Gamaleya institute or Johnson & Johnson.

Backers of the Gamaleya candidate, the first Russian COVID-19 vaccine, underscored the difference between their jab, based on a adenovirus in humans, and the British contender with an adenovirus found in monkeys.

“We have consistently drawn attention to human adenoviral platform being much safer and much more studied than any other new platform,” the head of Russia’s sovereign wealth fund Kirill Dmitriev told Reuters.

In choosing a monkey virus, AstraZeneca, as well as Leukocare, are trying to avoid the risk of the immune system attacking the vector, due to a previous bout with an adenovirus.

The decision to put the trial on hold has impacted clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions, Stat said.

Serum Institute of India said its trials of AstraZeneca’s vaccine were ongoing and had not faced any issues.

The U.S. National Institutes of Health, which is providing funding for AstraZeneca’s trial, declined to comment.

Moderna said in an emailed statement it was “not aware of any impact” to its ongoing COVID-19 vaccine study.

Leading U.S. and European vaccine developers pledged on Tuesday to uphold scientific safety and efficacy standards for their experimental vaccines.

Nine companies, including AstraZeneca, Moderna and Pfizer, issued an “historic pledge” after concerns that safety standards might slip under political pressure to rush out a vaccine.

The other signatories were Johnson & Johnson, Merck & Co, GlaxoSmithKline, Novavax Inc, Sanofi and BioNTech.

(Reporting by Guy Fauconbridge, Estelle Shirbon, Kate Kelland in London, Deena Beasley; Additional reporting by Peter Henderson in San Francisco, Rocky Swift in Tokyo, Sangmi Cha in Seoul and Miyoung Kim in Singapore; Editing by Alexander Smith)