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INSTANT VIEW 7-UK approves AstraZeneca/Oxford COVID-19 vaccine

Dec 30 (Reuters) - Britain on Wednesday became the first country in the world to approve a coronavirus vaccine developed by AstraZeneca and Oxford University as it battles a winter surge driven by a new, highly contagious variant of the virus.

While the approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) is a vindication for a shot seen as essential for mass immunisations, it does not eliminate questions about trial data that make it unlikely to be approved so rapidly by the European Medicines Authority (EMA) or United States.

JONATHAN STOYE, GROUP LEADER, RETROVIRUS-HOST INTERACTIONS LABORATORY, THE FRANCIS CRICK INSTITUTE

“In light of the sharply increasing number of cases, the approval of the Oxford/AZ vaccine is tremendous news ... However, the reported news does leave unanswered a number of important questions, particularly regarding the longer term.

“These include: What is the real efficacy of the vaccine? How well does it work in older people? Does it prevent virus transmission from person to person?

“What do we really know about dosing schedules? If the original study design called for a four-week interval between first and second doses, how much firm information do we have about varying this time? Is there flexibility to extend this period beyond 12 weeks?”

SAAD SHAKIR, DIRECTOR OF THE DRUG SAFETY RESEARCH UNIT (DSRU) NEAR SOUTHAMPTON

“Published data from the main efficacy study of the Oxford/AZ vaccine in clinical trials was 62% and 90% with different strengths of the first dose.

“The chairman of the JCVI said that the single dose of AZ vaccine is 70% efficacious based on limited unpublished data. More needs to be known because many points about these decisions remain unclear. MHRA and JCVI promised to provide more information urgently.”

ENRICO BUCCI, BIOLOGIST AND EXPERT IN SCIENTIFIC DATA ANALYSIS AT TEMPLE UNIVERSITY IN PHILADELPHIA “I am very puzzled. Even taking into account the mishaps that have occurred in their trials to date, we should know much more. But there is very little data available.

“The first point to clarify is to know the level of protection from the first dose for the following 12 weeks. We need to understand this in order to establish whether, in the midst of a pandemic, it might be more useful to vaccinate a smaller group of people at a shorter interval in order to stop the virus from spreading.”

JEREMY FARRAR, DIRECTOR OF WELLCOME TRUST

“To start 2021 with the rollout of a second vaccine – and one which has many advantages for global supply – is a moment to be celebrated. It does not mark the end of this crisis – in the UK and around the world there are still many, many difficult months ahead.

“As normal for any vaccine, there will be a need for close and continued monitoring for safety and efficacy as it is delivered. We will also need to continue tracking and improving our understanding of how long the protection lasts and whether they can prevent transmission.”

WORLD HEALTH ORGANIZATION (WHO) SPOKESMAN TARIK JASAREVIC

“We welcome this news because of the delivery attributes, the potential scale and affordability.”

JENS SPAHN, GERMAN HEALTH MINISTER

“We can expect another approval, next week, for the vaccine from Moderna. And with the approval today in the United Kingdom for Astrazeneca, I would also expect that a corresponding application will be examined thoroughly and quickly by the authorities in the European Union.

“Vaccination is the key to getting out of this pandemic. Preventing death and suffering is key. It is the key to getting our normal lives back.”

STEPHEN EVANS, PROFESSOR OF PHARMACOEPIDEMIOLOGY, LONDON SCHOOL OF HYGIENE & TROPICAL MEDICINE

“Authorisation of this vaccine, with usual cold-chain requirements, will mean that a global approach to the global pandemic becomes easier.

“The separate decision by the UK body responsible for setting policy in its use, the Joint Committee on Vaccination and Immunisation (JCVI), to allow both the currently UK authorised vaccines to be given with a greater delay between doses to maximise the numbers getting one dose as rapidly as possible is a sensible one.

“This will not bring a rapid return to life as it was before COVID-19, but is a very major step on the way.”

PROFESSOR ROBERT READ, HEAD OF CLINICAL AND EXPERIMENTAL SCIENCE WITHIN MEDICINE, UNIVERSITY OF SOUTHAMPTON

“This is a tremendous day for all of us ... The impact will take a few weeks to be seen but I am certain it will be significant.

“JCVI has advised that whilst we should be prepared to give people the second dose, it is acceptable to give that within 12 weeks of the first dose. This allows some much needed flexibility in a programme as big as this.”

LUCIO ROVATI, CEO OF ITALY’S ROTTAPHARM BIOTECH, WHICH IS WORKING WITH TAKIS BIOTECH ON A COVID-19 VACCINE

“It is good that the approvals are coming quickly. On this one, I would have recommended an extra moment of reflection, at least on the basis of publicly available scientific information. I believe that this will be EMA’s position.”

ANTONELLA VIOLA, PROFESSOR OF IMMUNOLOGY, UNIVERSITY OF PADUA

“It is a bad message that disorients citizens ... the EMA declared the data insufficient and MHRA granted approval. While there is no doubt about the safety of the vaccine, the efficacy is unclear and too many errors and announcements have complicated the interpretation of the data.”

DANNY ALTMANN, PROFESSOR OF IMMUNOLOGY, IMPERIAL COLLEGE LONDON

“Scientists don’t use terms like ‘game-changer’ lightly, but that’s what this is. Currently, the virus is once again proving that it can devastate by outrunning even our most draconian efforts to break transmission by limiting contact.

“To get out of this debacle there is no alternative to having a significant majority of the population carrying a high level of neutralising antibodies. With today’s announcement, that comes within our grasp.

“I await the modelling, but I suspect this will speed things by several months. An immune population by the spring starts to look feasible.”

MATT HANCOCK, UK SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE

“This is a moment to celebrate British innovation - not only are we responsible for discovering the first treatment to reduce mortality for COVID-19, this vaccine will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease.

“It is a tribute to the incredible UK scientists at Oxford University and AstraZeneca, whose breakthrough will help to save lives around the world. I want to thank every single person who has been part of this British success story.

“While it is a time to be hopeful, it is so vital everyone continues to play their part to drive down infections.”

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