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Dealing with a pandemic as severe and widespread as Covid-19 requires scientific collaboration, said a Sanofi medical director. The National.
The Paris-based pharmaceutical firm, which worked on a vaccine for SARS, another type of coronavirus, plans to build on its previous experience with that candidate to work on two different vaccines for Covid-19.
Sanofi is part of the largest vaccine race the world has ever seen, fueled by the urgency of the Covid-19 pandemic, which has claimed the lives of nearly 150,000 people so far and infected more than 2.1 million.
Millions have been praying for a vaccine and at least 78 candidates for the virus are known to be in development, four of which have gone through human trials, two from China and the United States.
“Coping with a pandemic as daunting as Covid-19 requires collaboration,” said Tamer Pehlivan, Medical Director for Africa, the Middle East, Eurasia, South Asia.
“Viruses mutate and can sometimes be harmless or dangerous, like Covid-19. A vaccine must be tailored for that strain. Developing a vaccine from scratch takes years, but we can build on what we have learned from previous efforts and potentially shorten the development schedule, ”he added.
Recombinant DNA candidate GSK
On Tuesday, Sanofi announced that it will join forces with GlaxoSmithKline to work on a vaccine for Covid-19. Sanofi will contribute its Covid-19 protein S antigen, which is based on DNA technology. This technology has produced an exact genetic match to the proteins found on the surface of the virus and helped to produce the licensed recombinant influenza product of Sanofi in the USA. USA
GSK will contribute its adjuvant technology. The use of an adjuvant can reduce the amount of vaccine protein required per dose, allowing more doses of vaccine to be produced, and thus helping to protect more people, which is useful in a pandemic. An adjuvant is added to some vaccines to enhance the immune response, and it has been shown to create stronger and longer lasting immunity against infections than the vaccine alone. It can also improve the likelihood of administering an effective vaccine that can be manufactured to scale.
Combining a protein-based antigen with an adjuvant is a well-established technique that has been used in several vaccines, including diphtheria, tetanus, and Sanofi influenza vaccines.
The companies plan to carry out the first phase of clinical trials in the second half of 2020 and, if successful, aim to complete the development required for availability in the second half of 2021.
“The research and materials can be produced relatively quickly for clinical trials because we have a licensed vaccine based on this platform, and we have the ability to manufacture large quantities of the candidate vaccine,” said Mr. Pehlivan.
This is not the first time that GSK and Sanofi have worked together. They had been working on a test of an experimental HIV vaccine, but it was abandoned in February after a tentative analysis of the data suggested that it was no more effective than placebo at preventing infection. Sanofi hopes that their latest collaboration will be more successful.
Translate Bio candidate mRNA
A virus particle is spherical in shape, with dozens of spikes on its surface. When it attacks a human by entering through the eyes, mouth, or nose, these spikes will bind to a protein called ACE2, which is found on the surface of cells in the respiratory tract.
Once the spike has latched onto the protein, it injects its own RNA, a genetic material similar to DNA that transforms instructions and forms proteins for the body.
But the virus essentially tricks the infected cell, which reads its own RNA instructions as if it were its own. The cell produces millions of copies of the virus before it breaks down. This cycle is repeated until the body can fight the virus or the person succumbs to it.
RNA is key to Sanofi’s other candidate for Covid-19 with Massachusetts-based clinical stage messenger RNA (mRNA) therapy company Translatebio. It hopes to be ready for the clinic by the end of this year and available on the market in late 2021.
Translate Bio has started producing multiple mRNA constructs and will use its mRNA platform to discover, design and manufacture a series of candidate vaccines against SARS-CoV-2. Sanofi will use its previous vaccine experience and the support of its external research networks to advance vaccine candidates for possible further development.
“A dedicated manufacturing space is being built through a contract manufacturing partner to accommodate two 250-gram batches per month. Depending on the final human dose, Translate Bio’s mRNA platform holds excellent promise for meeting future demands for a pandemic response, ”said Mr. Pehlivan.
A European authority
The United States-based Advanced Biomedical Research and Development Authority (BARDA) was established to protect the public from chemical, biological, radiological and nuclear threats (CBRN), as well as pandemic influenza and emerging infectious diseases. There is currently no European equivalent for BARDA, but Sanofi is asking policy makers to form one to work with the industry and help accelerate the development of a treatment for Covid-19 and other diseases.
Sanofi is also cooperating with the Coalition for Epidemic Preparedness Innovations (CEPI), which launched in early 2017 in Davos and the Bill and Melinda Gates Foundation to try to increase the response to the pandemic.
“We are in weekly contact with the European Commission and the EMA to help them monitor the impact of Covid-19 on the supply of medicines and vaccines in Europe,” said Mr. Pehlivan.
“As part of these discussions, we urge the authorities to: guarantee the free circulation of medicines, grant priority access to masks and disinfectants to the pharmaceutical industry (in addition to health personnel) to guarantee the supply of medicines and limit the demands for creating compulsory stocks to guarantee access to all critical medicines. “
In the short term, Sanofi is looking for treatment options.
“While a vaccine could be more than a year away, we are currently investigating two Sanofi products for the management of COVID-19: Plaquenil and Kevzara, with the corresponding regulatory authorities.”
Updated: April 17, 2020 11:40 PM
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