A pill that prevents the coronavirus from spreading in the body could soon be the world’s first oral anti-viral medication for COVID if approved by regulators.
Merck has announced it is applying for emergency use of its drug molnupiravir in the USA after its trial was so positive it was asked to wind up early.
Merck said its interim clinical trial results, which are yet to be peer reviewed, found the tablet cuts the risk of hospitalisation or death by about half.
The medication, which was originally developed to treat influenza, acts by targeting an enzyme that the virus uses to replicate itself, thus limiting COVID’s spread in the body.
During the trial of 775 patients who had COVID, none who were taking the medication died versus eight deaths in the placebo group.
Merck is the first company in the world to report trial results of a pill to treat COVID and said it would apply for emergency use in the USA within two weeks.
The US president’s chief medical advisor Dr Anthony Fauci said the trial results were “impressive” and the company’s application would go through the approval process.
“The news of the efficacy of this particular antiviral is obviously very good news,” said Dr Fauci.
“The company when they briefed us last night had mentioned they would be submitting their data to the FDA imminently.
“The data are impressive. There was a 50 per cent diminution.
“Of important is that in the placebo group there were eight deaths and in the treatment group there were no deaths, that’s also very important.
“We always hesitate to make any timelines. The FDA will look at the data and in their usual effective and very efficient way will examine the data as quickly as they possibly can and then it will be taken from there.”
The pill could be an additional tool in the arsenal against COVID but vaccination is considered the best method to prevent infection in the first place.
Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug within five days of COVID-19 symptoms had about half the rate of hospitalisation and death as those who received a dummy pill.
The study tracked 775 adults with mild-to-moderate COVID-19 who were considered high risk for severe disease because of health problems such as obesity, diabetes or heart disease.
The results have not been reviewed by outside experts, the usual procedure for vetting new medical research.
Among patients taking molnupiravir, 7.3 per cent were either hospitalised or died at the end of 30 days, compared with 14.1 per cent of those getting the dummy pill.
The results were so strong that an independent group of medical experts monitoring the trial recommended stopping it early.
The US government has committed to purchasing enough pills to treat 1.7 million people, assuming the FDA authorises the drug.
Mandatory vaccination job fears
There are fears of job losses and labour shortages after Victoria announced mandatory vaccination for authorised workers.
Hundreds of thousands of Victorians were issued an ultimatum on Friday: get vaccinated in two weeks or risk losing your job.
All Victorian authorised workers must have their first vaccine dose by October 15 and a second by November 26 to keep working on site, as part of a new statewide mandate.
The requirement will cover retail workers, personal trainers, MPs, journalists, faith leaders, judges, police, lawyers, actors and professional sportspeople.
Of the 1.25 million estimated authorised workers in the state, Premier Daniel Andrews said more than a million had already had their first dose.
He argued the policy shift was needed to curb rising case numbers after the state reported another 1143 infections and three deaths.
The state government has also revealed its plan to restart the construction industry from Tuesday after a two-week shutdown in Melbourne and other locked-down regions.
Eyes on the sky
Vaccinated Australians will soon be able to travel overseas followed by seven days home quarantine after the prime minister announced the country’s international borders would reopen next month.
The resumption of international flights has been earmarked for mid-November, as Australia’s COVID-19 vaccination rollout draws to a conclusion.
Unvaccinated people or those without approved jabs will require two weeks’ managed isolation in hotels or dedicated facilities.
However states and territories will access the new freedoms at different times with vaccination coverage and home quarantine programs varying across jurisdictions.
Qantas has brought forward the restart of its international flights to November 14 and will operate four weekly return flights between Sydney and London and three weekly return flights between Sydney and Los Angeles.
More flights will be added to meet demand.
However, the airline says once the exact date that Australia’s international borders will reopen in November is known, the commencement dates for the two routes may need to be updated.
Customers booked on the flights will have the flexibility to make ‘fee free’ date changes for travel until December 31, 2022, with refunds or credits available if flights are cancelled.
All passengers will be required to be fully vaccinated and return a negative test 72 hours prior to departure, and home quarantine for seven days on arrival into Australia.
The decision comes as states and territories edge closer to 80 per cent double-dose vaccination coverage for people aged 16 and over – the threshold for reopening the international border.
Prime Minister Scott Morrison said the time had come to give Australians back their lives.
“I want us to get moving. I want people to be able to come home,” he told reporters in Canberra.
China’s Sinovac and Covishield produced in India will be recognised alongside AstraZeneca, Pfizer, Moderna and Johnson & Johnson.
People who cannot be immunised including those under 12 or with a medical condition will be treated as vaccinated.
In coming weeks, Australians will be able to access an international vaccination certificate to present at foreign borders and at the Australian border.
The certificate, which will meet International Civil Aviation Organisation standards and be endorsed by the World Health Organisation, will display a QR code that is as secure as a passport chip.
They are expected to become available by the end of October, both digitally and in printable form, through the myGov platform.