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Merck COVID-19 pill effective, but more experts will continue to review safety

US federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy.

The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness.

The agency isn’t required to follow the group’s advice.

READ MORE: What is the new COVID-19 variant in South Africa

The FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects that were identified in studies of the pill in animals.

Given those risks, the FDA will ask its advisers next Tuesday whether the drug should never be given during pregnancy or whether it could be made available in certain cases.

Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients.

Given the safety concerns, FDA said Merck agreed the drug would not be used in children.

Other side effects were mild and rare, with about two per cent of patients experiencing diarrhea.

Regulators also noted Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies.

“While the clinical safety database was small, there were no major safety concerns identified,” FDA reviewers concluded.

READ MORE: Expert says 'no need to worry' about new COVID-19 variant yet

Additionally, the FDA flagged a concern that Merck’s drug led to small changes in the virus's signature spike protein, which it uses to penetrate human cells.

Theoretically, FDA cautioned, those changes could lead to dangerous new variants.

FDA will ask its independent advisers to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks.

All COVID-19 drugs currently authorised by the FDA require an injection or IV and can only be given by health professionals.

If authorised, Merck’s drug would be the first that US patients could take at home to ease symptoms and speed recovery.

It is already authorised for emergency use in the UK.

The meeting marks the first time regulators have publicly reviewed a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans.

The drug, molnupiravir, has been shown to significantly cut the rate of hospitalisations and deaths among people with mild-to-moderate coronavirus infections.

READ MORE: Flood warnings after NSW and Queensland lashed by wild weather

Drugmaker Merck is making a treatment for coronavirus.

Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’s genetic code to stop the virus from reproducing.

But that genetic effect has raised concerns that in rare cases the drug could cause birth defects or even spur more virulent strains of the virus.

Pregnant women were excluded from Merck’s study, and both women and men in the study were instructed to use contraception or abstain from sex.

For its part, Merck says results from two company studies in rodents show the drug does not cause mutations or damage to DNA at the doses studied.

FDA reviewers also confirmed previously reported interim results from Merck that the pill cut the rate of hospitalisation and death by about half among patients with early symptoms of COVID-19 who faced increased risk due to health problems.

However, on Friday morning Merck announced updated results from the same study that showed a smaller benefit from the drug.

The FDA said it is still reviewing the updated data and would present a new assessment of the drug's effectiveness next Tuesday.

Among more than 1400 adults in a company study, molnupiravir reduced the combined risk of hospitalisation and death by 30 per cent, less than the 50 per cent initially reported based on incomplete results.

READ MORE: New omicron variant stokes world fears, triggers travel bans

Nearly seven per cent of patients who received Merck’s drug within five days of COVID-19 symptoms ended up in the hospital and one died.

That compared to 10 per cent of patients hospitalised who were taking the placebo and nine deaths.

Merck didn't study its drug in people who were vaccinated for COVID-19.

But the FDA will ask advisers to recommend which patients may stand to benefit the most from the drug, based on vaccination status and underlying health problems.

While Merck’s drug is likely to be the first pill for coronavirus in the US, more are expected to follow.

Rival drugmaker Pfizer has submitted its own antiviral for FDA review after initial study results showed it cut the combined rate of hospitalisation and death by nearly 90 per cent.

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, which revolutionised the treatment of HIV and hepatitis C.

They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns that have been raised with Merck’s drug.

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Four people rescued after cars swept away in NSW floodwaters

Four people have been rescued from floodwaters in the north of NSW.

Emergency services carried out two separate rescues when a car was swept away in floodwaters at Burrell Creek and Muswellbrook.

The first incident saw a Landcruiser swept from a small causeway by rising floodwaters in Burrell Creek about 3.30pm yesterday.

READ MORE: What is the new COVID-19 variant in South Africa

Four people have been rescued after cars were swept into floodwaters in NSW.Four people have been rescued after cars were swept into floodwaters in NSW.

The car was carried 200 metres downstream where it became wedged on rocks in the middle of the flooded creek.

Two men, aged 46 and 30, went into the floodwaters to try and help the trapped 35-year-old driver.

Five officers attended the incident.

One of the officers found a rope and threw it about 10 metres to the three stranded men.

Police rescued them by pulling them individually across the floodwaters.

All three were assessed at the scene by paramedics but didn't need further treatment.

READ MORE: Flood warnings after NSW and Queensland lashed by wild weather

Four people have been rescued after cars were swept into floodwaters in NSW.

In the second incident, a Toyota Hilux had attempted to cross the Rosebrook Spillway in Muswellbrook before being swept from the road into floodwaters around 10.20pm last night.

Police found the car about 400 metres from the spillway with floodwaters rising over the vehicle's bonnet.

Officers tried to winch the car from the water but were unsuccessful.

The 52-year-old driver climbed out of the car and tried to swim against the floodwaters but instead began drifting further downstream with the vehicle.

Police waded through the water to assist him before he was safely returned to shore.

He was treated by paramedics at the scene before being taken to Muswellbrook Hospital for observation.

READ MORE: Expert says 'no need to worry' about new COVID-19 variant yet

Paddocks are flooded in NSW as the rain continues.

Assistant Commissioner Peter McKenna praised the officers involved in both the rescues.

"In the face of extreme danger, these officers acted quickly and courageously to ensure the stranded motorists were safely rescued," Assistant Commissioner McKenna said.

"Floodwater is extremely dangerous as it can have fast-moving undercurrents that can wash people and vehicles away."

The wild weather that has hit NSW has become dangerous, as a woman suffered spinal injuries after a tree fell on a car in Sydney's south overnight.

Gunnedah in the NSW north-west has been hit by flooding.

The NSW State Emergency Service (SES) received more than 850 calls for help overnight and performed 34 flood rescues.

Assistant Commissioner McKenna urged people not to drive, ride or walk through floodwaters.

More wet weather is forecast in the coming week with the state already saturated with rain.

The rain has caused Sydney's Warragamba Dam to hit capacity and begin to spill.

Further flooding is expected as a result of the deluge.

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Two black holes may have just exploded with light

In a world first, astronomers may have detected light signals produced from the collision of two black holes deep in space.

A black hole is a region of space where the gravitational pull is so intense nothing, not even light, can escape it once inside a region known as the event horizon.

Now scientists using Caltech's Zwicky Transient Facility located at Palomar Observatory near San Diego think they may have spotted the first known light flare from a pair of colliding black holes.

READ MORE: What is Omicron, the new COVID-19 variant in South Africa

Collision of two black holes producing light.

When two black holes collide they send out gravitational waves, which ripple across space and can be detected by sensitive instruments on Earth.

This was how the black hole merger was first identified on May 21, 2019.

READ MORE: Defence tactics to stop hazardous asteroids hitting Earth

Two gravitational wave detectors — the National Science Foundation's Laser Interferometer Gravitational-wave Observatory, and the European Virgo detector — picked up on the ripples.

One the merger was detected, scientists from the Zwicky Transient Facility facility were on the watch for light signals from the location were the gravitational wave signal originated.

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Inmate at Sydney prison charged with murder of fellow prisoner

An inmate at a Sydney prison has been charged with murder after another inmate was found dead.

Corrective Service NSW officers found a 63-year-old man lying on the floor of his cell at Silverwater prison about 11.30am on November 23.

Despite the efforts of the correctional officers, the man was declared dead by paramedics.

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An aerial view of Sydney's Silverwater Correctional Complex.

Police began investigating the circumstances around the man's death.

Officers arrested a 29-year-old inmate at the facility about 1.45pm yesterday.

The man was charged with murder and will appear before Parramatta Bail Court today.

READ MORE: Warragamba Dam spill puts NSW residents on flood alert