British-Swedish drugmaker AstraZeneca, which has partnered with Oxford University for a COVID vaccine, expects results from the late-stage trials later this year, depending on the rate of infection among trial participants.
Currently, there are over 200 vaccine candidates under development and the vaccine being developed by Oxford and licensed to British drugmaker AstraZeneca is seen as a front-runner.
Work on the Oxford viral vector vaccine, called AZD1222 or ChAdOx1 nCoV-19, began in January. It is made from a weakened version of a common cold virus that causes infections in chimpanzees.
The chimpanzee cold virus has been genetically changed to include the genetic sequence of the so-called spike protein which the coronavirus uses to gain entry to human cells. The hope is that the human body will then attack the novel coronavirus if it sees it again.
AstraZeneca has said it is committed to providing broad and equitable access to the potential vaccine on a not-for-profit basis during the pandemic.
Earlier this month, AstraZeneca Plc said that Britain’s health regulator had started an accelerated review of its potential coronavirus vaccine.
In rolling reviews, regulators are able to see clinical data in real time and have dialogue with drug makers on manufacturing processes and trials to accelerate the approval process.
The approach is designed to speed up evaluations of promising drugs or vaccines during a public health emergency.
AstraZeneca beat third-quarter sales estimates as demand for its diverse portfolio of drugs remained strong during COVID-19 pandemic lockdowns, and it maintained its 2020 forecasts.
Product sales, which exclude payments from collaborations, rose 7% to $6.52 billion for the three months ended Sept. 30 on a constant-currency basis, ahead of a company-compiled consensus of $6.50 billion.
However, the company reported core earnings of 94 cents per share, lower than analysts’ expectations of 98 cents.
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The World Health Organization has said the vaccines must be proven safe and effective in large (phase III) clinical trials. It said many vaccines are being studied, and some of the large clinical trials may report results in late 2020 or early 2021.
It said a series of independent reviews of the efficacy and safety evidence is required, including regulatory review and approval in the country where the vaccine is manufactured, before WHO considers a vaccine product for prequalification. Part of this process also involves the Global Advisory Committee on Vaccine Safety.
The WHO said an external panel of experts convened by it, called SAGE, will analyze the results from clinical trials and along with evidence on the disease, age groups affected, risk factors for disease, and other information, they will recommend whether and how the vaccines should be used.