Covid Chronicles VII

By lockdown_exit - 13th Sep 2020, 12:00 am - Covid Chronicles

The battle against Covid-19 suffered a setback earlier this week with late stage trials of the AstraZeneca/Oxford University vaccine under development being put on hold after 'a serious adverse event.' A possible reaction to the shot was reported in the UK. It's not clear what happened to the individual, but an adverse event is considered 'serious' if it requires hospitalization, is life-threatening or deadly. Stat News reported that the individual is expected to recover, but little else is known about his/her identity. The shot has been regarded as the best hope for a vaccine by the WHO and is one of nine in phase three trials - the last tests before approval can be sought.

However, AstraZeneca's coronavirus vaccine could still be available by the end of the year, or early next year, according to the company's chief executive, Pascal Soriot. Soriot was unable to say when the trial would resume but went on to say: "I still think we are on track for having a set of data that we would submit before the end of the year" for regulatory approval. We "could still have a vaccine by the end of the year," depending on how fast the regulator moves, he added.

By curious coincidence the decision to pause the AstraZeneca vaccine trial came a day after a number of manufacturers developing potential Covid-19 vaccines said they would be signing up to a joint safety pledge. Pfizer Inc, Johnson & Johnson and Moderna Inc are among the firms who, according to a WSJ report, "pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in their manufacturing processes...citing the draft of a joint statement that is still being finalised."

The unusual decision by pharma majors to take such a pledge comes amidst what could only be described as a "vaccine frenzy" with countries like Russia and China already claiming successful development of their own vaccines with the latter going so far as to claim that hundreds of thousands have been given Covid vaccinations with no adverse results so far.

Amidst the global race for a Covid-19 vaccine, early-phase trials in Russia have reportedly yielded positive results. The Covid-19 vaccine candidate, Sputnik-V, became the centre of controversy when it was first announced last month, due to a lack of Phase 3 trials before its efficacy was touted. However, two smaller trials suggest a double protection through T-cell responses within 42 days, according to findings published in The Lancet.

And there's pressure growing for an early vaccine in the U.S. where the Centers for Disease Control and Prevention (CDC) has told public health departments in all 50 U.S. states and five large cities to get ready to distribute a Covid-19 vaccine by 1 November, a "magic ballot" that Donald Trump believes will help him sail through the U.S. presidential election on 3 November.  President Donald Trump had said on August 27 that a vaccine might well be ready by the end of October. On the same day Robert Redfield, head of the CDC, sent the letter alerting public health departments. Several public health experts, including Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, previously said it was more likely that a vaccine would be available in 2021. However, Fauci said on 1 September that a vaccine might be available if the independent Data and Safety Monitoring Board decides that the ongoing clinical trials show overwhelmingly positive results.

And perhaps as an answer to Trump's prayers, U.S. drug maker Pfizer should know if a Covid-19 vaccine it is developing works, CEO Albert Bourla said on Thursday, potentially placing it at the centre of a bitter U.S. presidential politics dispute ahead of the November 3 election.

A coronavirus vaccine being developed by a partnership involving one of Britain's biggest drug companies has begun human trials. GlaxoSmithKline and Sanofi, of France, are enrolling 440 healthy adults in the trial at 11 locations across the USA to test the safety, immune response and the tolerability of the treatement. The results are expected as soon as early December, which would be the cue for a larger, late-stage trial before the end of the year. If the trials are successful, the companies plan to seek regulatory approval for the vaccine in the first half of next year.

And for those who have understandably lost count of the vaccines under trial - here's an update: There are 321 confirmed Covid-19 vaccine candidates, 32 of which have already entered clinical trials. However, to add to the confusion, WHO says there are only around 180 vaccines in development worldwide, including 35 in human trials. "No disease in human history has seen such rapid development in research. It's a testament to the incredible advances in science and technology the world has made in recent years," Director-General Tedros Ghebreyesus told reporters in Geneva last Friday. "It must be matched by its ambition to ensure as many people as possible have access to them." When asked about differing claims on vaccine arrival, including an aspiration by U.S. President Donald Trump to have a vaccine by October, the WHO's Chief Scientist Soumya Swaminathan said people should remember that "clinical trials take time."

Moving from preventatives to a possible treatment, Regeneron Pharmaceuticals said on Wednesday it expects to report biomarker data for its Covid-19 antibody cocktail by the end of this month. The drug maker last month struck a partnership with Roche to make and supply the Covid-19 antibody cocktail, which is being tested on several hundred patients after it prevented and treated the respiratory disease in animals.

To end on a trite note, every cloud has a silver lining and for Brazil, which has suffered one of the world's worst pandemic tolls, Covid-19 has been somewhat that way. Responding to the pandemic crisis the government has been distributing so much cash directly to citizens that poverty and inequality are approaching national historic lows. Some 66 million people, 30% of the population, have been getting 600 Reais ($110) a month, making it the most ambitious social programme ever undertaken in Brazil, a shocking shift under President Jair Bolsonaro who railed against welfare, dismissed the virus - and now finds himself newly popular. Would that things were the same elsewhere in the undernourished world.

Lalita Panicker is Consulting Editor, Views, the Hindustan Times, New Delhi