Amid question of full indemnification by some pharma companies from any risks from their vaccines by purchasing countries, Dmitriev clarified that Russia will not follow such approach as it has demonstrated the safety and efficiency of its human adenoviral vector platform, including its Sputnik V vaccine. … [Read more...] about Suspension of AstraZeneca Covid-19 vaccine trials showed fallacy of approach: RDIF CEO
Astrazeneca covid 19 vaccine candidate
AstraZeneca Plc has paused a late-stage trial of one of the leading COVID-19 vaccine candidates after a suspected serious adverse reaction in a study participant, health news website Stat News reported on Tuesday. It quoted an AstraZeneca spokesperson as saying in a statement that the "standard review process triggered a pause to vaccination to allow review of safety data.” The study is testing a COVID-19 vaccine being developed by AstraZeneca and University of Oxford researchers at various sites, including the United Kingdom, where the adverse event was reported. Russia seeks India’s help for Covid-19 vaccine’s Phase-3 trial, production The Russian government has sought India’s help in manufacturing the Sputnik V vaccine and conduct Phase-3 trials or bridging studies in the country … [Read more...] about AstraZeneca puts COVID-19 vaccine trial on hold over safety concern: Report
The AstraZeneca spokesperson’s statement said that “in large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.” Stat reported that serious adverse reactions vary and can include issues that require hospitalization, life-threatening illness and death. … [Read more...] about AstraZeneca puts Covid-19 vaccine trial on hold over safety concern: Report
Covid-19: the current count in IndiaIndia's total tally of novel coronavirus (Covid-19) cases is 4,367,436, while 3,396,027 people have recovered and the death toll is at 73,923, as per the latest update by the Health Ministry. Pune becomes the first district to register over two lakh cases in India, as per data of the Maharashtra government's health department. Worldwide, the virus has infected 27,733,819 people and killed 901,836. Finance ministry reaches out to states on GST In a bid to resolve the issue of pending dues, the Finance Ministry on Tuesday reached out to the states again clarifying that it would pay entire goods and services tax (GST) compensation to them amid the mounting opposition over the borrowing options proposed in lieu of the shortfall in indirect tax collections, sources told IANS. "It has never been the stand of the Union finance minister that the loss of revenue due to Covid would not be compensated. The Central government has, time and again, committed that … [Read more...] about Covid Speed Read: FinMin promises to pay GST dues; Russia releases first batch of Covid-19 vaccine for public
What is different about Phase-3 part of the trial?Each of these stages can take several months and that includes the time taken to recruit patients as well as the time involved in observing the effects of drugs and vaccines at various intervals of time. Such data is again sent to regulators, who, if satisfied, give the green signal for Phase-3. In this stage, the drug or vaccine is tested at multiple locations in thousands of volunteers or patients. In the case of a drug, this is the stage when a new drug is compared to the existing standard of care and when it must prove that it is either more efficacious, or is of similar potency but is safer, better tolerable or delivers any of the goods that the drugmakers had claimed when making the drug. In the case of a vaccine for a new disease, there is usually nothing to compare it to, so Phase-3 becomes a larger version of the Phase-2 trial. A Phase-3 trial is held at multiple locations to capture the demographic variability in the … [Read more...] about The Hindu Explains | Why is Phase-3 of COVID-19 vaccine trial complicated?