Tag Archives: GlaxoSmithKline

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

By Ludwig Burger, Patricia Weiss and Caroline Copley

FRANKFURT (Reuters) – Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunizations 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 politicized debate over what action is needed to rein in COVID-19 quickly and to jump start global business and trade.

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 criticize 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 program.

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 center 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 prioritize 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 and Timothy Heritage)

GSK, partner Vir join race to find COVID-19 antibody treatment

(Reuters) – GlaxoSmithKline and partner Vir Biotechnology have started testing their experimental antibody on early-stage COVID-19 patients, entering the race to find a winner in a promising class of antiviral drugs to combat the pandemic.

The British drugmaker said on Monday the long-acting single injection will be tested on recently diagnosed high-risk cases for its ability to prevent hospitalization, typically a life threatening disease stage.

GSK, which in April moved to invest $250 million in Vir and agreed to collaborate on the antibody, is behind some peers in developing the class.

Regeneron, which is working on antibody manufacturing with Roche, expects initial data from ongoing trials of its COVID-19 two-antibody combination in September.

Eli Lilly, working with biotech firm AbCellera, early this month started testing whether their antibody can prevent the infections in nursing homes. A separate trial testing the compound on recently diagnosed COVID patients may yield initial data in September or shortly after.

“We’re coming into the clinic a little bit later and part of that is because we spent some time selecting what we believe will be a best-in-class antibody,” Vir Chief Executive George Scangos told Reuters.

The antibody is designed to not only block the virus from invading cells but also to recruit immune cells to kill already infected cells, which would otherwise replicate the virus.

It also has been altered to stay effective for several months on a single shot and to cling to a part of the virus’s outer spike protein that has shown no tendency to mutate.

After testing the drug on an initial 20 U.S. participants over two weeks for safety, the trial will expand to 1,300 patients globally.

GSK said initial results could be available by the end of the year, complete results during the first quarter of 2021, and early access to patients could be on the cards before June.

GSK’s more prominent role so far in combating the pandemic has been in providing adjuvants, efficacy boosters that play a vital role in many vaccines.

The global effort to develop a vaccine against the virus, which has so far claimed more than 800,000 lives globally, has seen recent launches of late-stage trials, but work on treatments has also gone into overdrive.

While one approach has been to quell a dangerous overreaction of the immune system, known as cytokine storm, another has been to block the virus from invading cells with antibodies.

Antibodies, part of the body’s adaptive immune system, are normally made by white blood cells in response to a foreign substance in the body.

But pharma companies, also including AstraZeneca and Molecular Partners, are working on manufactured monoclonal antibodies, made in bioreactors from living cells, for a more targeted attack on the virus.

Using plasma from recovered COVID-19 patients, which contains a range of antibodies, is a similar approach but it may be fraught with more complex logistics and less consistent quality than manufactured antibodies.

In future studies, GSK and Vir plan to run more trials on their antibody’s ability to prevent the infection and treat patients that are already in hospital care. Later this year, they plan to start a trial of a second antibody from the collaboration.

(Reporting by Ludwig Burger; editing by David Evans)

U.S. inks $1.5 billion deal with Moderna for 100 million doses of COVID-19 vaccine

By Jeff Mason and Carl O’Donnell

(Reuters) – The United States has entered an agreement with drugmaker Moderna Inc to acquire 100 million doses of its potential COVID-19 vaccine for around $1.5 billion, the company and White House said on Tuesday.

The United States in recent weeks has made deals to acquire hundreds of millions of doses of potential COVID-19 vaccines from several companies as part of its Operation Warp Speed program, which aims to deliver a vaccine in the country by the end of the year.

Moderna’s price per dose comes to around $30.50 per person for a two dose regimen.

With the exception of its deal with AstraZeneca, which offered a lower price per drug in exchange for upfront research and development costs, all the deals price COVID-19 vaccines between $20 to $42 for a two dose course of treatment.

Moderna’s vaccine candidate, mRNA-1273, is one of the few that have already advanced to the final stage of testing and is on track to be completed in September, the company said this month.

Moderna’s deal with the U.S. only pays out in full if the drugmaker hits certain unspecific timing benchmarks for vaccine delivery.

The United States has advanced purchase agreements with Johnson & Johnson, AstraZeneca Plc, Pfizer Inc and BioNTech SE, and Sanofi SA and GlaxoSmithKline Plc for their respective vaccine candidates.

The agreements would lock in more than 500 million doses of COVID-19 vaccine for the U.S., assuming that the companies involved receive regulatory approval. Some deals also give the United States an option to purchase additional doses.

The U.S. government previously gave Moderna around $1 billion to fund its research efforts, bringing total U.S. funding to around $2.5 billion.

Other countries, including Japan, the United Kingdom and Canada, have forged similar deals with drugmakers.

(Reporting by Jeff Mason and Carl O’Donnell; Editing by Peter Henderson, Chris Reese and Tom Brown)