Sunday, September 26

GSK / Sanofi Covid vaccine delayed until the end of next year | Coronavirus


A coronavirus vaccine being developed by GlaxoSmithKline and its French partner, Sanofi, will be delayed until the end of next year after trials revealed it did not elicit a strong immune response in older people.

Pharmaceutical companies expected to have regulatory approval for the candidate vaccine in the first half of 2021, but interim results from a phase 1/2 trial showed an “insufficient” response in those over 50, the most vulnerable age group. to severe coviditis. 19.

The results released Friday are a stark reminder that despite a string of positive results from vaccines produced by Pfizer / BioNTech, NIH / Moderna and Oxford University / AstraZeneca, developing effective vaccines at high speed is not a task. simple.

In people 18 to 49 years of age, the GSK / Sanofi vaccine produced an immune response similar to that seen in patients recovering from Covid-19, but in older adults, companies reported a “low immune response .. probably due to insufficient antigen concentration. ”Antigen is the viral protein that primes the immune system to fight coronavirus.

The companies will now reformulate the vaccine and launch a phase 2 trial in February with the goal of administering approved vaccines in the last quarter of 2021, barring further mishaps.

Britain has reserved 60 million doses of the GSK / Sanofi vaccine as part of its portfolio of 355 million injections from seven different vaccine developers. This week, the UK launched the first of 40 million shots of the Pfizer / BioNTech vaccine. The Oxford / AstraZeneca vaccine is expected to join the mass vaccination program, but is awaiting approval from the UK regulator.

Fast guide

When and how will I be able to receive the Covid vaccine in the UK?

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Now that the UK has authorized the first Covid vaccine, who will get it first?

The government’s Joint Committee on Vaccination and Immunization (JCVI) says its priority is to prevent Covid-related deaths and protect health and social care personnel and systems.

Nursing home residents and their caregivers are first on the JCVI list because their risk of exposure to the virus is higher and because the risk of death is closely correlated with advancing age. They are followed as a priority by any other person over the age of 80 and front-line health and social care workers.

Still, for pragmatic reasons, NHS staff are likely to be the first group to take the hit from Pfizer / BioNTech. This is because the vaccine must be stored at extremely cold temperatures, which can be more easily achieved using hospital facilities.

Are there enough doses to reach all priority groups?

Together, nursing home residents, their caregivers and those over 80 years old number nearly 6 million people, and frontline NHS staff 736,685 more. Matt Hancock, the health secretary, has said that he expects 10 million doses of the Pfizer / BioNTech vaccine to be available this year, so if this is the only licensed vaccine, everyone else would have to wait until there are more doses. available next year.

Where will I go for the vaccine?

Covid-19 vaccines are expected to be delivered to three types of locations: trusted NHS “vaccine centers” in hospitals; mass vaccination centers, which are being installed in places like football stadiums, conference buildings and racetracks; up to 5,000 people a day are expected to be vaccinated; and in GP and pharmacy consultations. GPs can also visit nursing home residents and homebound patients without travel.

How far apart will the two doses be administered and will I be protected after the first?

While there is some evidence to indicate high levels of short-term protection with a single dose of vaccine, a two-dose schedule is what has been approved by the MHRA.

The second dose should be given at least 21 days after the first, and both will be injected into the deltoid muscle, the thick triangular muscle that we use to lift each arm.

For the Pfizer vaccine, its efficacy rate was calculated seven days after the second injection. People will likely have some protection before this, but this is how long it will take for full protection to kick in. We will learn more about the scope of protection and how long it lasts as data from ongoing clinical trials arrives.

Can I pay to get the vaccine privately?

Unlikely. England’s Deputy Chief Medical Officer Jonathan Van-Tam has said he believes Covid-19 vaccines should be administered according to clinical priority rather than allowing people to skip the queue if they can afford them.

Will I be able to choose which vaccine I have?

It is also unlikely, at least in the short to medium term. Assuming more than one vaccine is approved, the priority will be to distribute any available doses to people who need them as quickly as possible.

Linda Geddes

Roger Connor, president of GSK Vaccines, said the study results “were not what we expected,” adding: “It is also clear that multiple vaccines will be needed to contain the pandemic.

“Our goal now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, to make a significant contribution to the prevention of Covid-19.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said the results highlighted why many scientists were in awe of the success of the BioNTech, Moderna and Oxford vaccines.

“The first vaccines that reached an interim analysis in phase 3 trials were unusual for having gotten this far without notable problems,” he said. “This shows what we know: that it is not always easy to develop a new vaccine to the point of being used to prevent disease. Obtaining a vaccine that demonstrates efficacy in the relevant age and in other groups is not an easy path; many uncertainties may persist ”.

Evans said it was possible that adjusting the doses and components of the vaccine could improve responses in older people, but that it was not guaranteed.

“It shows that we need to continue developing vaccines for Covid-19, because not all vaccines will reach the point of completing phase 3 trials with proven efficacy and without serious harm, and even those that do can run into problems after introduction that restrict or even prevent its widespread use.

“We are certainly not at the end of the Covid-19 vaccine process and there will be things that will surprise us as we move forward. While any delay is disappointing, it shows that the vaccines are not as simple to produce as early successes might have implied, ”he said.


www.theguardian.com

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