A coronavirus vaccine hopeful invested in by the British Government was dealt a devastating blow today as manufacturers revealed it won’t be done until late 2021.
Clinical trials of the jab by GlaxoSmithKline and French company Sanofi showed that their jab did not appear to work well in middle-aged and elderly people.
These are the ones most at risk of dying from Covid-19 and therefore are a key group for any vaccine-maker to target. Full clinical trial information has not been published by the manufacturers said they were unhappy with the early results.
The UK in July secured 60million doses of the prospective treatment, but it was today announced that any jab will likely not be ready before the end of 2021.
It puts a dent in hopes that a more conventional vaccine could be developed to fight the pandemic.
Britain is currently rolling out the Pfizer/BioNTech shot, which uses cutting-edge technology but needs to be stored at ultra-low temperatures – throwing up a series of logistical problems in storing and distributing the jab.
GSK’s vaccine is based on the existing technology used to produce Sanofi’s seasonal flu vaccine, so should have been a reliable option for investors.
But the phase two trials – ones that look for an immune response before testing whether the jab actually protects against coronavirus – have not gone well.
An employee works on a production line at the factory of British multinational pharmaceutical company GlaxoSmithKline (GSK) in Saint-Amand-les-Eaux, northern France
The UK in July secured 60million doses of the treatment, but any jab will now not likely be ready before the end of 2021
Genetic material from the surface protein of the Covid virus is inserted into insect cells – the basis of Sanofi’s influenza product – and then injected to provoke an immune response in a human patient.
Pfizer’s approved vaccine, for comparison, was shown to be more than 94 per cent effective in adults over 65.
Elderly people are more vulnerable to Covid, and disease in general, because as the body ages the immune system becomes weaker and slower to respond.
People with underlying health conditions or on immunosuppressant drugs such as chemotherapy are also at greater risk.
Sanofi and GSK said they planned to launch another study next year, hoping to come up with a more effective vaccine.
The French drugmaker said today’s results showed ‘an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.’
Sanofi said it would launch a phase 2b study in February of next year instead after a recent challenge study in non-human primates performed with an improved antigen formulation demonstrated better effects.
It said: ‘The study will include a proposed comparison with an authorized COVID-19 vaccine.
‘If data are positive, a global Phase III study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.’
An employee works on the tanks which will be used for the manufacture of the adjuvant in the Covid-19 vaccines, at the factory of British multinational pharmaceutical company GlaxoSmithKline in Saint-Amand-les-Eaux, northern France
The two companies said they had ‘updated governments and the European Commission where a contractual commitment to purchase the vaccine has been made.’
The Government has ordered 40million doses of the Pfizer jab and the first were administered to the over-80s in hospitals this week.
It has also bought 7million doses of the Moderna vaccine and 100million of the much-anticipated Oxford/AstraZeneca vaccine, both of which are awaiting approval.
UK ministers will now pin their hopes on Oxford University’s vaccine, which also uses traditional vaccine technology and is easier to store and transport than Pfizer’s.
Oxford’s jab is a viral vector vaccine which uses a genetically modified weakened form of the common cold which trains the body to be able to fight Covid-19.
Viral vector vaccines – used to immunise people against HPV and meningitis – are tried and tested and scientists have a better idea of their safety profiles.
Oxford’s jab can be stored in a normal medical fridge and batches can be split into smaller amounts and delivered to smaller sites such as care homes, which was not possible with Pfizer’s.
Britain’s regulator is reviewing the vaccine and is expected to give it approval in the coming days or weeks.
THE SIX CORONAVIRUS VACCINES BRITAIN HAS PRE-ORDERED
BIONTECH/PFIZER – 40MILLION
This is the first coronavirus vaccine so far that has been shown to work, having been found to be 90 per cent effective in a trial of more than 43,000 people.
There are some concerns about the two-dose jab, because it needs to be largely kept in ultra-cold storage at around minus 70C.
But the interim results suggest it is one of the most successful vaccines ever developed. It uses genetic code in a fat droplet to instruct the body to make the coronavirus spike protein, which causes the body’s immune system to produce antibodies.
Ugur Sahin and his wife Oezlem are the brains behind the vaccine and the German couple’s company BioNTech is developing it with US pharmaceutical giant Pfizer. The UK is promised ten million doses by the end of the year, and 30million next year. So far only hundreds of thousands have been produced.
OXFORD UNIVERSITY/ ASTRAZENECA – 100MILLION
Results on this vaccine are hoped for this week. Up to 100million doses have been promised to the UK, and 13,000 British volunteers have taken part in global trials.
The vaccine uses a deactivated chimpanzee cold virus, containing genetic code which triggers cells to produce the spike protein on the outside of the coronavirus, so the body can recognise it and fight it off.
JANSSEN – 30MILLION
An international trial of 30,000 people, including 6,000 in the UK, starts today, measuring the effectiveness of two vaccine doses. It works like the Oxford vaccine, but uses a common cold virus to deliver the genetic code which triggers cells to produce the spike protein of the coronavirus.
NOVAVAX VACCINE – 60MILLION
The vaccine from US biotech firm Novavax began being tested in a UK study in September and has so far recruited 10,000 people.
The vaccine contains a synthesised copy of the coronavirus spike protein and a ‘booster’ to enhance the immune response. There are 60million doses promised to the UK, which it is hoped will be available by mid-2021.
VALNEVA – 60MILLION
This is a traditional vaccine unlike the more innovative design from BioNtech. The immune system is safely exposed to an inactivated version of the coronavirus.
Up to 190million doses are promised to the UK, although it has not yet been tested on people. Up to 100million of those are set to be manufactured at the company’s facilities in Livingston, near Edinburgh. It is not expected to be available until late next year.
GSK/SANOFI – 60MILLION
British drugs giant GlaxoSmithKline has reportedly already manufactured millions of doses of a ‘booster’ for three vaccines.
The firm is providing its adjuvant technology and has partnered with Sanofi, Medicago and Clover Pharmaceuticals. The first results on whether one of the three traditional protein-based vaccines work are expected in the first half of next year.