SINGAPORE: The Health Sciences Authority (HSA) on Monday (Aug 1) granted temporary authorisation for AstraZeneca’s COVID-19 antibody medication for adults who are medically unsuitable for vaccination against the coronavirus.
The Evusheld treatment comprises 2 monoclonal antibodies and it is administered via intramuscular injection.
HSA said the treatment is approved for the prevention of COVID-19 in grown-ups who have not had a known recent contact with someone infected with all the disease and are improbable to mount a good adequate immune response to COVID-19 vaccination.
This may be due to their immunocompromised state from a medical condition or from receiving immunosuppressive medications or even treatments.
Such medical conditions or treatments include those people who are in an immunocompromised state from organ, blood or bone marrow transplants, immune insufficiencies, human immunodeficiency pathogen (HIV) infections, along with the use of corticosteroids or other immunosuppressive medicines.
The Evusheld jab is not a substitute for vaccination in individuals intended for whom the COVID-19 vaccine is recommended, said HSA.
“The treatment must be prescribed with a doctor and the suitability of use on the person patient will require the careful clinical evaluation by the prescribing physician. ”
“RELATIVE RISK REDUCTION”
HSA said the particular drug’s efficacy data was based on an ongoing Phase 3 study in more than 5, 000 participants elderly 18 to 99.
The participants were all unvaccinated and either had risk factors for inadequate COVID-19 vaccination response or increased risk for coronavirus infection.
Results showed that there was a “relative risk reduction” of symptomatic COVID-19 illness simply by 77 per cent with Evusheld compared to a placebo, with a length of protection of about six months for non-Omicron variants of the SARS-CoV-2 virus.
“At the time the clinical study had been conducted, the circulating variants of concern integrated Alpha, Beta, Gamma, and Delta, ” said HSA.
Recent in-vitro data showed that particular Omicron subvariants are less susceptible to Evusheld, hence the period of protection contrary to the subvariants is currently unidentified, HSA added.
According to Reuters, the lab-made antibodies in Evusheld are designed to stick around in the body for months in order to contain the virus in case of an infection.
HSA said safety information also showed the drug was “well-tolerated” and the incidence associated with adverse events reported in the clinical study were generally reduced.
Typical adverse events documented were mild in order to moderate in severity, and included headaches, throat pain, runny nose, nasal congestion and muscle pain.
“While the study reported a higher incidence of cardiovascular adverse events along with Evusheld, the causal relationship has not been established based on current accessible data, ” stated HSA, adding it will continue to closely monitor for any “further cardiovascular safety signal”.
The particular available clinical evidence “preliminary demonstrated” that will Evusheld has a good benefit-risk profile for your prevention of COVID-19 in individuals who are unlikely to mount a sufficient immune response to the particular COVID-19 vaccines or even for whom COVID-19 vaccination is not suggested.
“Emerging data on Evusheld’s effectiveness against the currently circulating Omicron version will be required to more determine its continued benefits, ” mentioned HSA.
As there was no clinical data upon pregnant women, breastfeeding moms and children, simply no recommendation could be made in these groups, the particular agency added.
CONTINUOUS REVIEW OF DATA
Evusheld was granted temporary authorisation under the Pandemic Special Access Path (PSAR), which allows for early access to critical novel vaccines, medicines and medical gadgets during a pandemic.
HSA mentioned it will actively review the evolving effectiveness and safety data to ensure that the benefits of Evusheld continue to outweigh the particular known risks.
“As a condition for the interim authorisation under PSAR, AstraZeneca is required to collect and submit the relevant basic safety data from continuing clinical studies to guarantee the continued safety plus efficacy of Evusheld, including its effectiveness against prevailing versions, ” it additional.
PSAR interim authorisation might be terminated if new data suggest that the advantages of Evusheld no longer outweigh the risks.
“To obtain complete registration for Evusheld, AstraZeneca will need to publish the complete dataset depending on prevailing international standards. ”