KUALA LUMPUR, May 13 – The National Pharmaceutical Regulatory Agency (NPRA) has conditionally approved AstraZeneca’s antibody cocktail to prevent Covid-19 in individuals who may not respond well to vaccination.
The Malaysian drug regulator authorised use of Evusheld, a combination of two monoclonal antibodies (tixagevimab and cilgavimab), in those aged 12 years and older weighing at least 40kg who may not obtain a sufficient immune response to Covid-19 vaccination, or who are not recommended for inoculation.
Evusheld is meant to prevent Covid-19 infection in individuals before potential exposure to the SARS-CoV-2 virus that causes Covid-19.
“This product is not intended to replace Covid-19 vaccination and public health measures, especially compliance with SOPs (standard operating procedures) that must still be continued,” Health director-general Dr Noor Hisham Abdullah said in a statement yesterday in announcing the NPRA’s conditional approval for Evusheld.
The United States’ Food and Drug Administration’s (FDA) emergency use authorisation for Evusheld only permits the Covid-19 medication for individuals who are not currently infected with Covid-19 and who have not recently been exposed to someone infected with Covid-19.
FDA’s authorisation also requires that individuals either have moderate to severely compromised immune systems and may not mount an adequate immune response to Covid-19 vaccination, or who are not recommended for Covid-19 inoculation due to a history of serious side effects to a coronavirus vaccine.
One dose of Evusheld is administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession) for pre-exposure prevention of Covid-19 for six months.
Malaysia’s NPRA approved Evusheld dosage of 100mg/ml each for tixagevimab and cilgavimab.
AstraZeneca said in a statement last April 20 that Phase Three trial results, published in medical journal New England Journal of Medicine, showed Evusheld reduced the risk of developing symptomatic Covid-19 by 77 per cent in the main analysis, and by 83 per cent in a six-month follow-up, compared to placebo.
No cases of severe disease or death from Covid-19 were recorded in participants who received Evusheld in the six months after they received the prophylactic antibody cocktail.
According to the CovidNow site, the vast majority of Malaysians have been fully vaccinated against Covid-19, at 93 per cent of adolescents aged 12 to 17 and 98 per cent of adults aged 18 and older.