Press review

 - 

Covid-19 vaccine makers lobby EU for legal protection

LONDON, 28 Aug (APM) - The European pharma industry's vaccines lobby is putting pressure on the EU for exemptions which would protect its members from lawsuits if there are problems with any new coronavirus vaccines, the Financial Times reported on Tuesday.
It quoted people with knowledge of the discussions and an internal memo seen by the paper.
The pandemic has compressed vaccine research and development, that can take years, into months. Some potential vaccines are already in Phase III. At the same time, governments around the world have poured cash into research and development to try to save lives and prevent economically crippling lockdowns, the FT said.
It quoted a memo, circulated to members by Vaccines Europe, a division of trade body the European Federation of Pharmaceutical Industries and Associations, as saying: "The speed and scale of development and rollout do mean that it is impossible to generate the same amount of underlying evidence that normally would be available through extensive clinical trials and healthcare providers building experience."
The document says that this creates "inevitable" risks.
For this reason, Vaccines Europe said in its memo it was advocating a "comprehensive no-fault and non-adversarial compensation system and an exemption from civil liability".

Flu jab push

The Times on Wednesday reported that UK government ministers will ask the National Health Service to administer flu jabs not normally licensed for use in the UK as part of an expanded vaccination programme this winter.
Health chiefs want to vaccinate half the population, twice as many as usual, to reduce pressure on the NHS and prevent hospitals being hit by a combined surge of flu and Covid-19 patients, the paper said.
However, the decision to enlarge the programme was made only last month, long after vaccine orders are normally placed and manufacturers have planned accordingly.
The Times quoted a source as saying that this had meant governments across Europe being "really flexible" and agreeing to use vaccines "not fully licensed", despite being used in other markets.
A total of 30 million people in England will be eligible for a flu jab from next month.
Jonathan Leach, honorary secretary of the Royal College of GPs, said the expanded programme poses a "huge logistical challenge for the health service".

U.S. announces emergency authorisation of convalescent plasma for Covid-19 patients

The U.S. has announced the emergency authorisation of convalescent plasma for Covid-19 patients, said The Observer on Sunday.
The paper said that more than 64,000 Covid-19 patients in the U.S. have already been given convalescent plasma but that there is no solid evidence that it fights the virus.
The story also covered U.S. president Donald Trump's criticism of the Food and Drug Administration (FDA) for what he sees as attempts to delay approval decisions until after the U.S. presidential election in November.
He tweeted: "The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after 3 November. Must focus on speed, and saving lives!"
The Observer said the 'deep state' conspiracy theory holds that a permanent government of bureaucrats exists to thwart the president’s agenda.
Former FDA commissioner Scott Gottlieb defended the agency in an interview with CBS’s Face the Nation that was picked up in the article.
"I firmly reject the idea they would slow-walk anything or accelerate anything based on any political consideration or any consideration other than what is best for the public health and a real sense of mission to patients."
The Daily Mail covered the EAU on Monday, saying it puts pressure on the UK to routinely treat Covid-19 patients with the blood of survivors.
The paper also acknowleged concerns from scientists, quoting Dr Eric Feigl-Ding, an epidemiologist and senior fellow at the Federation of American Scientists.
"I have very mixed feelings," he said. "I don’t think they should endorse it with such an aggressive FDA move given the lack of trial data."
The Times covered the story on Tuesday, leading with comments from UK scientists on the failure to establish a large randomised control trial to test the treatment in the U.S.
Martin Landray, professor of medicine and epidemiology at Oxford University, said: "It is unfortunate that despite the scale of the epidemic in the United States and their rich history of rigorous clinical research, so many patients continue to be given an unproven treatment. If just a few thousand patients were to be randomised, we would have the answer. If effective, convalescent plasma could be rapidly used worldwide."

U.S. considering fast-tracking regulatory review for AstraZeneca's coronavirus vaccine

The Financial Times at the weekend said that the Trump administration is considering bypassing normal U.S. regulatory standards to fast track AstraZeneca/Oxford University's experimental coronavirus vaccine ahead of November's election, citing three people briefed on the plan.
The paper said that possible options include awarding the FDA's emergency use authorisation to the vaccine in October based on results from a small trial in the UK.
The FT suggested that making a vaccine available before the election could allow Trump to claim he has "turned the tide on the virus", which has killed more than 170,000 people in the U.S.
The FT said the source of the story was a person who was briefed on a 30 July meeting between Mark Meadows, White House chief of staff, and Steven Mnuchin, treasury secretary, and Nany Pelosi, the Democratic speaker of the House of Representatives.
Pelosi warned there should be "no cutting corners" in the vaccine approval process, said the source.
The paper quoted an AstraZeneca spokesperson who said the company has "not discussed emergency use authorisation with the U.S. government."
This was followed up by the Guardian on Monday and the Times on Tuesday, with both publication quoting remarks from that AstraZeneca said it has "not discussed emergency use authorisation with the U.S. government and it would be premature to speculate on that possibility".
The company added that "late stage Phase II/III trials for [the vaccine] are ongoing in the UK and other markets globally, and we do not anticipate efficacy results until later this year".
The Times also quoted Danny Altmann, a professor of immunology at Imperial College London, who said: "It should be incredibly disturbing to the global medical community to see any potential attempts by any politicians, whether in Russia, the USA or elsewhere, to seek to manipulate, short-circuit or exert influence in any way over the agreed scientific protocols that are in place to carefully evaluate comparative safety, immunogenicity and efficacy of vaccines."

Cambridge University coronavirus vaccine trial could start in autumn

The Telegraph on Wednesday reported that a coronavirus vaccine candidate developed by the University of Cambridge could begin clinical trials in the UK in the autumn. (APMHE 68665)
A £1.9 million funding boost from Innovate UK, the Government's innovation agency, has provided support for a collaboration between Cambridge spin-off company DIOSynVax, the University of Cambridge and the University Hospital Southampton NHS Foundation Trust, the paper said.

Moderna's vaccine immune response in old and young

Moderna has reported that early data of its experimental coronavirus vaccine show it induced immune responses in older adults that were similar to younger participants, the Mail reported on Wednesday. (APMHE 68656)
The company is one of the leading U.S. contenders in the race to develop a safe and effective vaccine against Covid-19 and its candidate, mRNA-1273, is already in Phase III.
However, this marks the first time the company has released data on how well its immunisation works in older patients, the Mail added.

Hydroxychloroquine does not treat Covid-19 - study

Hydroxychloroquine, touted by President Donald Trump as a "game changer" and a "gift from God" in the fight against Covid-19, does not treat the disease and may even raise the risk of death, another study has found, the Mail reported on Thursday. (APMHE 68683)
A review of 29 scientific studies showed the controversial anti-malarial drug does not save the lives of infected patients.

Vertex's new cystic fibrosis drug to be available on NHS in UK

The Guardian at the weekend reported on the European approval for Vertex Pharmaceuticals' Kaftrio to treat cystic fibrosis (APMHE 68632).
The approval means the drug will be available in the UK under a previous agreement between NHS bodies in England and Scotland and Vertex, said the paper.
Clinical trials have shown Kaftrio can increase lung function by between 10% to 14% in people with cystic fibrosis, depending on their genetic makeup, and can improve quality of life.

Pandemic forces 1,500 clinical trials to close in UK

The Observer on Sunday picked up research by Southampton University that found more than 1,500 clinical trials of new drugs and treatments had been permanently closed in the UK as a result of Covid-19 restrictions, while a further 9,000 had been suspended.
Michael Head, who carried out the analysis, told The Observer: "This pandemic has knocked everything off track. Research gives us the knowledge we need to tackle illnesses in new ways, and if that doesn’t happen all areas of health will suffer."
The Times picked up the story on Monday.

AstraZeneca launches trial of monoclonal antibody combination for Covid-19

AstraZeneca has started a clinical trial of a combination of two monoclonal antibodies to help prevent and treat Covid-19, said the Guardian and The Telegraph on Tuesday.
The drug, known as AZD7442, is being tested in a trial that will include up to 48 healthy volunteers in the UK aged 18 to 55. (APMHE 68651)
The antibodies come from patients infected with coronavirus and were discovered by Vanderbilt University Medical Centre and then licensed to AstraZeneca in June, said The Telegraph.

UK trial of coronavirus treatment for people with diabetes

The Times on Tuesday reported that a UK project to develop a potential coronavirus treatment for people with diabetes has raised £10 million from investors and has begun an advanced clinical trial.
The compound was developed by AstraZeneca and licensed to St George Street, a medical charity led by academics and former drugs industry executives. It is now in a Phase II trial involving 150 patients in 30 hospitals in the UK.

Vaccine prioritisation in U.S.

The FT on Tuesday reported on comments from leading U.S. figures that poor and minority communities must be among the first to receive a Covid-19 vaccine once it is approved in the U.S.
It quoted Helene Gayle, head of the U.S. vaccine distribution committee: "When deciding who gets the vaccine first, we want to think about who is most likely to be affected by death and severe illness; we want to think about how the virus is being transmitted; and we want to think about issues of equality. This has been a virus that has disproportionately affected communities of colour and low-wage workers."
The U.S. vaccine distribution committee was set up by the Centers for Disease Control and Prevention and the National Institutes of Health. It is run by the National Academy of Medicine.

Most promising Covid-19 medicines

The Guardian on Monday had a roundup of the six "most promising" treatments for Covid-19:
  • dexamethasone - a low dose steroid that is available as a cheap generic
  • convalescent blood plasma - plasma containing antibodies to the virus collected from people who have recovered from Covid-19
  • remdesivir - Gilead's antiviral that has been authorised for emergency use in the U.S., India and Singapore and approved in the European Union, Japan and Australia for use on people with severe symptoms
  • tocilizumab - an antibody normally used to treat rheumatoid arthritis
  • blood pressure pills - a study has shown that the risk of critical illness or death from Covid for people with high blood pressure was found to be significantly lower if they were taking angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB)
  • inhaled interferon beta - a small study from scientists at Southampton University suggests that an inhaler containing the drug interferon beta, used to treat multiple sclerosis, could be effective.

Teva charged in U.S. price-fixing investigation

The FT said on Wednesday that Teva has been charged in the U.S. with conspiring to fix the price of generic drugs, including a common cholesterol treatment, after it refused to settle with the U.S. Department of Justice. 
The Israeli company became the seventh drugmaker to be charged in the price-fixing investigation and was accused of participating in three separate conspiracies. Teva denied the allegations and said it would vigorously contest them in court, the FT reported. (APMHE 68663)
tm/nh/nm

[TM5QFKAHZ]

TRY APM HEALTH EUROPE AND GET ACCESS TO THE FULL CONTENT

Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to the latest stories

Our coverage includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.

REQUEST

an initial 10 day temporary access of APM Health Europe.