September 2020 • PharmaTimes Magazine • 12-13

// COVID-19  //


AZ seals deal with EC for coronavirus vaccine supply

AstraZeneca has finalised an agreement with the European Commission to supply up to 400 million doses of its AZD1222 COVID-19 vaccine.

Building on the existing agreement with Europe’s Inclusive Vaccines Alliance spearheaded by Germany, France, Italy and the Netherlands, this deal will give all EU member states the option to access the vaccine “in an equitable manner at no profit during the pandemic,” the company said. It also enables EU member states to redirect doses to other European countries, as needed.

“This first vaccine agreement with the European Commission will ensure that millions of Europeans have access to the AZD1222 vaccine following its approval,” noted AZ’ chief executive Pascal Soriot. “With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020”.

Recently published interim results from the ongoing Phase I/II COV001 trial, published in The Lancet, showed that the vaccine, which was co-invented by the University of Oxford and its spin-out company Vaccitech, was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.


Sanofi, GSK sign coronavirus vaccine deal with UK govt

Sanofi and GSK have reached an agreement with the UK government for the supply of up to 60 million doses of their COVID-19 vaccine.

The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.

Sanofi is leading the clinical development and registration of the vaccine, with a Phase I/II study scheduled to start in September followed by a Phase III trial by the end of this year. The firms believe regulatory approval could be achieved by the first half of 2021 if the trials are successful.

Sanofi and GSK said they are also are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.


Research to investigate
COVID-19 risk in BAME groups

Six new projects hoping to improve understanding of the links between ethnicity and susceptibility to COVID-19 are being funded by the NIHR and UK Research and Innovation (UKRI).

The projects will seek to explain and mitigate the disproportionate death rate from COVID-19 among people from Black, Asian and minority ethnic (BAME) backgrounds, including BAME health and social care workers.

Specifically, the projects will receive funding of £4.3 million to: explore the impact of the virus specifically on migrant and refugee groups; work with BAME communities to create targeted, digital health messages; introduce a new framework to ensure the representation of people from BAME backgrounds in COVID-19 clinical trials; and the creation of one the UK’s largest COVID-19 cohorts.

“Urgent action must be taken to determine and address the factors underlying this disparity,” added UKRI chief executive, Professor Dame Ottoline Leyser. “There is unlikely to be a simple answer and we must consider all possibilities, including the role of racial and social inequalities, so that we can save as many lives as possible during this pandemic and any future outbreaks.”


Second peak can be avoided with testing and tracing

Research co-led by UCL and the London School of Hygiene & Tropical Medicine has found that a second COVID-19 wave could be prevented if testing and tracing is scaled-up in the UK.

Using mathematical modelling calibrated to the UK coronavirus epidemic, the study explored the impact of combining test-trace-isolate strategies with reopening schools and more people returning to work from September.

The results of the modelling suggests that a second wave in the UK could be prevented with increased levels of testing – between 59%-87% of symptomatic people – as well as effective contact tracing and isolation.

The study estimates that, assuming 68% of contacts could be traced, 75% of those with symptomatic COVID-19 infection would need to be diagnosed and isolated if schools return full-time in September.

If these measures are not implemented, the authors of the study say the reopening of schools alongside gradual relaxing of lockdown measures are likely to cause a secondary wave that would peak in December 2020, if schools open full-time in September.


Pfizer links with Gilead on remdesivir manufacturing

Pfizer has inked a multi-year agreement with Gilead Sciences to manufacture and supply the investigational antiviral drug remdesivir for the treatment of COVID-19.

Under the terms of the deal, Pfizer will provide contract manufacturing services at its McPherson, Kansas facility in the US to manufacture and supply remdesivir for Gilead.

Following the agreement, Pfizer has become one of multiple external manufacturing organisations supporting efforts to scale up the supply of the promising investigational COVID-19 treatment.

“From the beginning it was clear that no one company or innovation would be able to bring an end to the COVID-19 crisis. Pfizer’s agreement with Gilead is an excellent example of members of the innovation ecosystem working together to deliver medical solutions,” said Albert Bourla, Pfizer’s chairman and chief executive.


Demand for mental health services to rise due to COVID-19

An NHS Confederation report has forecast that the peak in demand for mental healthcare in England is yet to come as the effects of the coronavirus pandemic continue to have an impact.

It highlights that some providers are predicting a 20% increase across all mental health services, while facing a 10%-30% reduction in how many patients they can care for at the same time due to necessary infection control and social distancing measures.

The Centre for Mental Health has predicted that an additional 500,000 people will require support for their mental health over the next two years.

The NHS Confederation is calling for national support to understand how demand for mental health services will vary from area to area as the pandemic continues, with financial and staffing resources to be allocated efficiently.


Roche, Regeneron to co-develop antiviral antibody combo

Roche and Regeneron have joined forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, the latter’s investigational antiviral antibody combination, to people around the globe.

According to the firms, REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in those exposed to the virus.

REGN-COV2 is currently being assessed in two Phase I/II clinical trials as a treatment of COVID-19 and in a Phase III trial for the prevention of COVID-19 in household contacts of infected individuals.

If it proves safe and effective and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the US and Roche will be responsible for distribution outside the US.

The collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion.


First coronavirus re-infection documented

Researchers in Hong Kong claim to have documented the first confirmed case of coronavirus reinfection, in a 33-year-old man who contracted the virus a second time 142 days after the original infection.

The second infection did not cause any symptoms. Researchers at Hong Kong University found that the viruses causing each case differed by 24 nucleotides, indicating infection by two different versions of SARS-CoV-2.

“Our results suggest SARS-CoV-2 may continue to circulate among humans despite herd immunity due to natural infection,” they said.

“This is a worrying finding for several reasons. The first, as is laid out in this manuscript, is that it suggests that previous infection is not protective. The second is that it raises the possibility that vaccinations may not provide the hope that we have been waiting for,” commented Dr David Strain, from the University of Exeter, as reported by The Independent. “Vaccinations work by simulating infection to the body, thereby allowing the body to develop antibodies. If antibodies don’t provide lasting protection, we will need to revert to a strategy of viral near-elimination in order to return to a more normal life.”

However others urged caution over the findings. Dr Jeffrey Barrett, from the Wellcome Sanger Institute, told the media that “seeing one case of reinfection is not that surprising even if it is a very rare occurrence.”