NZ Government urged to buy 'game changer' Covid-19 drug treatment
In New Zealand, the government is being asked to quickly approve and buy a type of drug that can fire up the immune system of people already sick from Covid-19, as well as reduce deaths and time spent in hospital.
Different from vaccines, monoclonal antibodies boost immunity to help prevent people becoming severely ill from the disease.
Already approved in Europe, the USand Australia, they are being labelled a "game changer" for at-risk populations.
In July, the Ministry of Health referenced one as promising but, as yet, there's been no approval from Medsafe and no buying by Pharmac.
There are two major monoclonal antibodies (Mabs) used for Covid: Regen-Cov (manufactured by Regeneron Pharmaceuticals) and Sotrovimab (by GlaxoSmithKline).
University of Otago professor Kurt Krause, an infectious diseases doctor, said Regen-Cov has been shown to be safe and effective, and it's highly likely Sotrovimab is too.
"This is just a game changer... It's extremely important that we acquire this as soon as possible," Krause said.
The Ministry of Health wrote in a July update that Regen-Cov was "showing promise", and referenced a "well-designed, phase three, randomised controlled" (yet non-peer reviewed) trial which said:
"Treatment with Regen-Cov was well-tolerated and significantly reduced Covid-19-related hospitalisation or all-cause death, rapidly resolved symptoms, and reduced viral load."
Scientists are not claiming the shot would replace a vaccine, rather it would add more protection, complementary to a vaccine.
A trial published in the New England Journal of Medicine found Regen-Cov, made up by a combination of two antibodies, was safe and effective, and reduced both infection and symptoms.
"Subcutaneous Regen-Cov prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, Regen-Cov reduced the duration of symptomatic disease and the duration of a high viral load," the NEJM article stated.
Various US states have reported success in preventing serious illness. For example yesterday South Carolina health officials estimated the treatment has prevented 200 deaths and 2000 hospitalisations in the state alone.
"It is remarkable how effective monoclonal antibodies can be in preventing progression of Covid-19 to severe disease. Keeping people at increased risk of severe disease out of the hospital," Assistant State Epidemiologist Dr. Jane Kelly said.
There are currently 22 people in New Zealand hospitals with Covid-19. One woman, in her 90s, died earlier this month, the only death of this current outbreak.
RNZ has been asking the Ministry of Health for the last two weeks about monoclonal antibodies but did not receive a response.
Dr Krause said he's personally contacted the government about it, and so have others in the field.
"I've written [to] the government to try find out where we are in the process with these monoclonal antibodies, and I haven't got any word back. I've also got colleagues that I know have written to the government. [The evidence is] convincing enough that I'd like to get some movement on this."
Following a potential exposure event - such as the Middlemore Hospital exposures - Krause said contacts could have been quickly given a shot which would reduce their chance of developing severe illness.
"Where if you've got a localised outbreak you can go in, interview all the people, give them the injection, and you'd block the risk of them becoming infected by over 80 percent," Krause said.
Generally the monoclonal antibodies (Mabs) are not required for healthy people who are not at added risk of serious illness from Covid-19. They are targeted towards older people or those with other added risk factors, such as asthma, kidney or lung disease, obesity or diabetes.
Australia approved one of them, Sotrovimab, and had it in the country ready to use in mid-August.
"The sotrovimab treatment requires a single dose to be administered through an intravenous (IV) infusion in a health care facility and has been shown to reduce hospitalisation or death by 79 percent in adults with mild to moderate Covid-19, who are at risk of developing severe Covid-19," Health Minister Greg Hunt said.
Director-General of Health Dr Ashley Bloomfield said yesterday Medsafe is considering one of the Mabs.
"I do know that there is a medication that was approved in the UK a couple of weeks ago and an application is with Medsafe, that was put in quite quickly, and is going through their process at the moment," Bloomfield said.
A medicine cannot be approved without an application from the manufacturer, Bloomfield added.
Prime Minister Jacinda Ardern said, while they are looking at treatments, they are no replacement for the vaccine which everyone should still get.
Source and quoting Radio New Zealand.
Yours sincerely
Frank Short
