The head of British drug manufacturer AstraZeneca said on Thursday further research was needed on its COVID-19 vaccine after questions emerged over the protection it offers, but the additional testing is unlikely to affect regulatory approval in Europe.
AstraZeneca and its partner, the University of Oxford, announced on Monday that it was seeking regulatory approval for the vaccine after it showed an average 70-per cent effectiveness.
That rate jumped to 90 per cent when an initial half-dose then a full dose was given, similar to that in rival vaccines in development by Pfizer/BioNTech and Moderna.
But US scientists have said the higher rate of effectiveness came during tests in people aged 55 and under, and was discovered by accident during the clinical trials.
The head of the Oxford Vaccine Group, Andrew Pollard, said this week that further evidence will be available next month, but the result was still ‘highly significant’.
‘Now that we’ve found what looks like a better efficacy, we have to validate this, so we need to do an additional study,’ AstraZeneca chief executive Pascal Soriot told Bloomberg.
He said he expected that to be another ‘international study but this one could be faster because we know the efficacy is high, so we need a smaller number of patients’.
The additional trial was not likely to delay regulatory approval in Britain and the European Union, Soriot said.
There are high hopes for the AstraZeneca/Oxford vaccine, which Pollard has hailed as a ‘vaccine for the world’ given that it could be cheaper to make, and easier to store and distribute.
It can be stored, transported and handled at normal refrigerated conditions of between two and eight degrees Celsius (36-46 Fahrenheit) for at least six months.
Pfizer/BioNTech’s offering requires temperatures of -70C, driving up costs and potentially making it out of reach for lower and middle-income countries.
AstraZeneca/Oxford has also promised to provide its vaccine to the developing world on a non-profit basis.
The World Health Organisation said it looked forward to the full publication of the data from the trial.
‘On a review of the detailed data, we will be better positioned to understand the vaccine performance,’ it said.
The chief medical officer for England, Chris Whitty, also cautioned against drawing premature conclusions, and urged patience until the data were published in peer-reviewed journals.
‘It’s always a mistake to make too many judgments early and in particular before the independent regulator has had a chance to look at the results,’ he told a news conference.
The British government said on Friday it has asked its independent medicines regulator to assess AstraZeneca’s coronavirus vaccine as part of the formal approval process for the drug to be rolled out by the end of the year.
AstraZeneca has completed Phase III clinical trials of its vaccine, the last stage before regulatory approval.
But under British rules, the government must also ask the independent Medicines and Healthcare products Regulatory Agency to green light the drug.
‘We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards,’ said Health Secretary Matt Hancock.
Britain has secured access to 100 million doses of the vaccine produced by the British drug manufacturer in partnership with the University of Oxford.
One of the developers of Russia’s Sputnik V coronavirus vaccine announced Friday that India-based drugmaker Hetero will produce over 100 million doses of the jab.
‘Hetero, one of India’s leading generic pharmaceutical companies, have agreed to produce in India over 100 million doses per year of the world’s first registered vaccine against the novel coronavirus infection -– Sputnik V,’ the Russian Direct Investment Fund said in a statement, adding that production was expected to start in early 2021.
Earlier this week, Russia said interim results from the Sputnik V clinical trials showed the vaccine was 95 per cent effective, similar to other international vaccine makers that have also published test results showing efficacy rates of 90 per cent and higher.
Russia also announced that the Sputnik V vaccine will be priced at $10 per dose on international markets, costing less than some other registered COVID-19 vaccines.
Russia was the first country to announce the registration of a coronavirus vaccine in August — dubbed Sputnik V after the Soviet-era satellite — but did so ahead of large scale clinical trials.
Currently the third and final phase of trials is underway, with some 40,000 volunteers involved in blind testing of the vaccine that uses two different human adenovirus vectors.
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