Pharmaceutical Market Europe • September 2020 • 10-11

CORONAVIRUS NEWS

EU aims to vaccinate 40% of population in initial COVID-19 blueprint

The European Union, Britain and other EU partners have agreed on a blueprint that plans to vaccinate 40% of their populations against COVID-19.

This target is double the goal set by the World Health Organization (WHO), which has laid out plans to initially buy enough vaccines for 20% of the world’s population.

The WHO’s scheme aims to provide vaccines for groups who are most vulnerable to COVID-19, including health workers and populations of lower-income countries.

The EU’s blueprint document has identified over 200 million people out of its 450 million strong population as belonging to a ‘priority group’, including those with certain diseases, the elderly and healthcare workers.

The document stated: ‘Adding (up) all risk groups presently known will designate probably 40% of the population, depending on the situation and demography in countries.’ The blueprint has been adopted by health experts from a number of EU member states, Britain, Switzerland, Norway and the Balkans.

Last week, WHO director-general Tedros Adhanom Ghebreyesus warned against vaccine nationalism as countries across the world step up efforts to secure early access to promising COVID-19 vaccines.

Although the EU vaccine plan has no particular timeline, its existence still raises concerns that it could reduce the availably of possible doses for less developed countries.


COVID-19 vaccine deals with the EU hindered by strict liability rules

Deals between vaccine developers and the European Union for a COVID-19 vac-cine are being hindered by strict liability rules that offer only partial protection against legal risks for potential shots, according to European officials.

An EU official told Reuters that EU governments “are ready to financially cover certain of the companies’ risks” but strict liability rules remain in place. Given the speed at which companies are currently developing vaccines for the novel coronavirus, there could be an increased risk of side effects with potential shots.

As a result of these increased risks, companies are placing importance on financial coverage on these liabilities in any government deals for early access to their respective vaccines.
However, the EU is maintaining rules that hold vaccine developers and other manufactures liable for their products, apart from certain rare cases, such as when they did not put the products into circulation.

EU officials involved in the negotiations between the EU and vaccine developers, including Johnson & Johnson and Pfizer, told Reuters that these talks have been hindered by the liability rules.

The EU has currently only reached one supply agreement for a potential COVID-19 vaccine with AstraZeneca and Oxford University. This deal only offers partial liability coverage for developers of the vaccine.

“The contract foresees that liabilities and financial costs are shared among the parties,” the Belgian medicines agency said in a statement about the deal reached by the European Commission with AstraZeneca and Oxford University.


EU to contribute €400m to WHO’s COVID-19 vaccine facility

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The European Commission (EC) has announced that it will contribute €400m to the World Health Organization’s (WHO) COVID-19 vaccine facility, COVAX.

The COVAX facility is co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. It aims to ensure equitable access to affordable COVID-19 vaccines across the globe.

“Today (31 August), the Commission is announcing a €400 million contribution to COVAX for working together in purchasing future vaccines to the benefit of low and middle income countries. I’m confident this will bring us closer to our goal: beating this virus, together,” said Ursula von der Leyen, president of the EC.

At the same time, the EC also confirmed its interest in participating in the COVAX facility, adding that the EU’s participation in COVAX will be complementary to the ongoing EU negotiations with vaccine companies.

COVAX is the vaccines pillar of the ACT-Accelerator, a global collaboration focused on accelerating the development, production and equitable access for COVID-19 tests, treatments and vaccines.
The facility aims to buy two billion doses of COVID-19 vaccines by the end of 2021, by negotiating with a portfolio of vaccine suppliers that are using different technologies for the development of their respective vaccines.


US pays $1.5bn for 100 million doses of Moderna’s COVID-19 vaccine

Moderna has reached an agreement with the US government for an initial 100 million doses of its vaccine candidate mRNA-1273, in the latest deal made as part of Operation Warp Speed.

The US will pay up to $1.525bn for the manufacturing and delivery of 100 million doses of the vaccine candidate, which includes incentive payments for ‘timely’ delivery of the vaccines.

The US, under its Operation Warp Speed initiative, will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna. The latest funding follows a previous cash injection from the US Biomedical Advanced Research and Development Authority (BARDA) totalling $955m.

Moderna has been at the forefront of the race to find an effective COVID-19 vaccine since it administered its candidate to the first patient in March.

The candidate, mRNA-1273, reached clinical testing stage in record time, taking only 63 days after Moderna received the genetic code of the virus. The candidate is also on track to complete the final stage of clinical testing in September, after the vaccine demonstrated promise in an early-stage study.

An interim analysis of a phase 1 study of mRNA-1273 showed that the vaccine produced rapid and strong immune responses against SARS-CoV-2, the virus which causes COVID-19.
Following two doses of the vaccine, neutralising antibody levels among participants were similar to those seen in individuals who had tested positive and recovered from COVID-19.


Novacyt launches diagnostic test to differentiate between COVID-19 and flu

Biotech company Novacyt has announced the launch of a new diagnostic test which can tell the difference between COVID-19 and the flu, as the winter flu season approaches.

The clinical diagnostics company said that its Winterplex test includes two gene targets specific to COVID-19, as well as gene targets for influenza A and B and respiratory syncytial virus (RSV).
According to the company, clinical trial data of the test demonstrated 100% specificity and between 96% and 100% sensitivity across the panel.

The new polymerase chain reaction (PCR) respiratory test can be used on any open PCR platform, including Novacyt’s portable q32 instrument.

PCR tests are the most preferred form of diagnostics for COVID-19, as they can be used to directly detect the presence of an antigen in the body, as opposed to just the presence of antibodies.

This is a more accurate way of distinguishing whether or not an individual has the disease, as the PCR test can detect viral RNA which will be present in the body before antibodies form. This means that PCR tests can tell whether someone has the virus soon after they catch it.
Novacyt’s COVID-19 PCR test has seen increasing demand since its launch earlier this year, with sales in June hitting €25.4m (£22.5m).

The company expects its new Winterplex test, combined with continued growth of its existing COVID-19 PCR test, to continue to drive growth well into next year.


Vaccine nationalism must be
prevented, says WHO director-general

World Health Organization (WHO) director-general Tedros Adhanom Ghebreyesus has warned against vaccine nationalism, as countries across the world secure early access to promising COVID-19 vaccines.

In an address made yesterday, the WHO director-general called on all countries to work collectively to end the pandemic, by sharing finite supplies “strategically and globally”.

“No one country has access to research and development, manufacturing and all the supply chains for all essential medicines and materials,” said Ghebreyesus.

“And if we can work together, we can ensure that all essential workers are protected and proven treatments like dexamethasone are available to those who need them,” he added.

Ghebreyesus encouraged countries to take into account the WHO’s recommendation for equitable allocation of COVID-19 vaccines, with doses to be given proportionally to all countries participating in its ACT-Accelerator.

The WHO also recommends that consideration should be given to countries in relation to threat and vulnerability, with front-line health and social care workers also due to be given priority.

“If we don’t protect these highest risk people from the virus everywhere and at the same time, we can’t stabilise health systems and rebuild the global economy,” said Ghebreyesus.