U.S., European COVID vaccine developers pledge to uphold testing rigour

[webfact]

U.S., European COVID vaccine developers pledge to uphold testing rigour

By Ludwig Burger, Patricia Weiss and Caroline Copley

 

FILE PHOTO: Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration taken taken April 10, 2020. REUTERS/Dado Ruvic

 

FRANKFURT (Reuters) - Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunisations will be held against in the global race to contain the coronavirus pandemic.

 

The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, issued what they called a "historic pledge" after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.

 

The companies said in a statement they would "uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines".

 

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

 

The promise to play by established rules underlines a highly politicised debate over what action is needed to rein in COVID-19 quickly and to jumpstart global business and trade.

 

U.S. and European vaccine makers have pledged not to cut any corners in the race to develop treatments for COVID-19. Julian Satterthwaite reports.

 

The head of the U.S. Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase Three clinical trials - large-scale testing intended to demonstrate safety and efficacy - as long as officials are convinced the benefits outweigh the risks.

 

This prompted a call for caution from the World Health Organization (WHO).

 

Developers globally have yet to produce large-scale trial data showing actual infections in participants, yet Russia granted approval to a COVID-19 vaccine last month, prompting some Western experts to criticise a lack of testing.

 

The head of China's Sinovac Biotech has said most of its employees and their families have already taken an experimental vaccine developed by the Chinese firm under the country's emergency-use programme.

 

Chinese companies or institutions, which are involved in several leading vaccine projects, did not sign the statement.

 

PROMISE ON SAFETY AND EFFICACY

"We want it to be known that also in the current situation we are not willing to compromise safety and efficacy," said co-signatory Ugur Sahin, chief executive of Pfizer's German partner BioNTech.

 

"Apart from the pressure and the hope for a vaccine to be available as fast as possible, there is also a lot of uncertainty among people that some development steps may be omitted here."

 

BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the centre of bitter U.S. politics before the Nov. 3 presidential election.

 

President Donald Trump has said it is possible the United States will have a vaccine before the election. His Democratic rival, Kamala Harris, has said she would not take his word alone on any potential coronavirus vaccine.

 

The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.

 

Among other hurdles, approval must be based on large, diverse clinical trials with comparative groups that do not receive the vaccine in question. Participants and those working on the trial must not know which group they belong to, according to the pledge.

 

BioNTech's Sahin said there must be statistical certainty of 95%, in some cases higher, and that a positive reading on efficacy does not come just from random variations but reflects the underlying workings of the compound.

 

The development race has intensified safety concerns about an inoculation, polls have shown.

 

Western regulators have said they would not cut corners but rather prioritise the review workload and allow for development steps in parallel that would normally be handled consecutively.

 

Sahin declined to comment on regulators specifically or on what events prompted the joint statement.

 

The chief executive of German vaccine developer Leukocare, which did not sign the pledge, was more forthright.

 

"What Russia did - and maybe also there are tendencies in the U.S. to push the approval of a vaccine which has not been sufficiently developed in clinic – bears a huge risk," said CEO Michael Scholl.

 

"My biggest fear is that we will approve vaccines that are not safe and that will have a negative impact on the concept of vaccinations in general."

 

Leukocare is working with Italy's ReiThera and Belgium's Univercells to produce a COVID-19 vaccine currently in phase I testing.

 

(Reporting by Ludwig Burger, Patricia Weiss in Frankfurt and Caroline Copley in Berlin; Editing by Susan Fenton, Timothy Heritage and Tom Brown)

 

-- © Copyright Reuters 2020-09-09

 

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[Walkabout]

AstraZeneca’s Covid-19 vaccine trial ON HOLD after adverse reaction of UK participant

https://www.rt.com/news/500207-astrazeneca-covid-vaccine-hold/

[Bkk Brian]

39 minutes ago, Walkabout said:

AstraZeneca’s Covid-19 vaccine trial ON HOLD after adverse reaction of UK participant

https://www.rt.com/news/500207-astrazeneca-covid-vaccine-hold/

Out of all the dozens of international media outlets that are running this today, you had to link to the Russia Today website 

 

Seeing as this occurred in a patient in the UK here's a UK press report https://www.independent.co.uk/news/world/astrazeneca-coronavirus-vaccine-trial-pause-hold-b420761.html

 

BBC also reported that the pause will probably only be for a few days.

[Walkabout]

@Bkk Brian

Out of topic, but I like to have a broader view of the world news and not limit myself to the “western” press . . .

[Bender Rodriguez]

the government already gave them (since 1986) NO REASON to make a safe product as they cannot be SUED, EVER

[Walkabout]

Yes, a reason enough not to get a vaccination.
I shall not get a Covid-19 vaccination as I do not believe in its effectiveness nor its safety. Here are a few points why:
-    Contagious diseases dropped significantly before the advent of vaccines as statistics from the 19th and 20th centuries show, a question knowing the source of illnesses (germs, . . .) hence the clean water, hygiene, . . .  ). Vaccines do not seem to have a significant effect statistically.
-    In the “developed” world, the country with the most infant vaccinations is the one with the highest infant mortality (the USA!). Infant mortality is proportional to the number of vaccine dosses received.
-    Vaccine manufacturers are protected from liability (e.g. in the USA). All the recent European governmental contracts for future delivery of Covid-19 vaccines include the exclusion of the manufacturer liability. This does not inspire confidence.
-    I have an autistic child after vaccination with a US vaccine in the Philippines . . . .

[NotYourBusiness]

Right. So if you can't have kids in 20 years, or it causes lymphoma in 20 years, all tested and accounted for.

[mybeat]

555

When Russia said they have vaccine everyone in the west itched about safety and now they want to skip on safety too? 

[puipuitom]

Did everyone already forgot the Softenon disaster ?

My wife and I are according to our family docter "high on the covid-19 hit list", but we will not rush for a vaccination. A few months extra voluntarily quarantaine is preferred.

[Paul Henry]

People who are anti vaccines generally look from a very limited perspective. We can look at a few diseases that have just about vanished because of vaccine, no doubt the knockers will find other reasons why these diseases are now the exception not the rule. Polio, chicken pox, measles, hepatitis A & B, diptheria. I could go on and list more but the history of medicine proves the point. As a 10 year old I was bedridden for 12 months with polio and still carry the memories and scars of this disease because no vaccine was available.

[Chomper Higgot]

“The promise to play by established rules underlines a highly politicised debate over what action is needed to rein in COVID-19 quickly and to jumpstart global business and trade.”

 

And:

 

”The head of the U.S. Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase Three clinical trials - large-scale testing intended to demonstrate safety and efficacy - as long as officials are convinced the benefits outweigh the risks.”

 

There you have it.

 

 

 

 

[Walkabout]

@ Paul Henry
. . . .perhaps, but even the "western" press is sometimes forced to admit the obvious . . . .
https://www.theguardian.com/global-development/2020/sep/02/vaccine-derived-polio-spreads-in-africa-after-defeat-of-wild-virus