August 1, 2022

HSA approves Covid-19 AstraZeneca jab for people medically unsuitable for vaccination

By brit

SINGAPORE – People who have not been able to get vaccinated against Covid-19 owing to health reasons can be prescribed AstraZeneca’s antibody drug to protect against the coronavirus.

In a statement on Monday (Aug 1), the Health Sciences Authority (HSA) said it has granted interim authorisation for the antibody drug cocktail called Evusheld, under the Pandemic Special Access Route.

Evusheld comprises two monoclonal antibodies and is administered by intramuscular injection, said HSA.

The two antibodies in the drug are derived from antibody-producing B-cells that were donated by recovering Covid-19 patients.

The treatment is authorised for adults who have not had a known recent exposure to a person with Covid-19 infection and are unlikely to mount an adequate immune response to Covid-19 vaccination due to a medical condition or are taking immunosuppressive medications or treatments or for whom Covid-19 vaccination is not recommended.

Examples of such people include those who are in an immunocompromised state from blood or bone marrow transplants or have human immunodeficiency virus (HIV) infections.

About 7 per cent of Singapore residents remain unvaccinated, according to the Health Ministry’s website.

Taking the Evusheld shot is not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended, said HSA.

“The treatment must be prescribed by a doctor and the suitability of use on the individual patient will require a careful clinical assessment by the prescribing doctor,” it added.

Results from a clinical study in more than 5,000 participants found that there was a relative risk reduction of symptomatic Covid-19 illness by 77 per cent with Evusheld compared with a placebo.

The drug had protected them for about six months against Covid-19 variants, excluding Omicron.

At the time the study was conducted, the circulating variants of concern included Alpha, Beta, Gamma and Delta, said HSA.

Efficacy data for Evusheld was based on an ongoing Phase III study with participants aged 18 to 99, who had not been vaccinated against Covid-19 and had risk factors for an inadequate Covid-19 vaccination response or an increased risk for infection.

Said HSA: “Recent in-vitro data has shown that certain Omicron subvariants are less susceptible to Evusheld.

“Hence the duration of protection against the Omicron subvariants is currently unknown.”

This means that more data is required to determine the drug cocktail’s effectiveness against the currently circulating Omicron variant to further determine its continued benefits, HSA said.