Company applies to register use of Ivermectin
One company has so far applied to register the use of the drug Ivermectin locally, but Chief Medical Officer Dr Jacquiline Bisasor-McKenzie says that a bioequivalence study, which is necessary for approval, has not yet been submitted.
The Medical Association of Jamaica (MAJ) had urged the Ministry of Health and Wellness (MOHW) to include the drug as part of the treatment options for COVID-19 patients. The association noted that Ivermectin had been safely used over several decades to treat various ailments and recommended its use as hospitals struggled to treat an increasing number of patients affected by the virus.
Despite the pressure from medical practitioners, the MOHW said that there wasn’t enough information to recommend for or against Ivermectin for use in COVID-19 treatment. Bisasor-McKenzie said two weeks ago that they would register the drug once an application is made but only for on-label use.
A bioequivalence study is a critical document that would state whether what is being registered is the same molecule as the one that has been studied. It also shows the safety and efficacy of the drugs being submitted.
“We have responded to the distributor to say that this information is needed. I also spoke to the director this morning to just reach out on a personal note to emphasise the importance of this document so that they can understand why we are waiting still and that they can make efforts to bring it in,” said Bisasor-McKenzie, who didn’t reveal the name of the company.
She was speaking at Wednesday’s meeting of joint select committee on the COVID-19 pandemic and related matters.
HOSPITALS STILL EXCEEDING CAPACITY
Although the number of active COVID-19 cases is declining, the committee was told, some hospitals continue to exceed their capacity to accommodate and treat these patients.
National epidemiologist Dr Karen Webster-Kerr said that the country won’t see the effects of the recently announced lockdown until a few weeks.
Jamaica had its first recent weekend lockdown last week, and the next scheduled one is slated to start this Saturday at noon.
In addition to the lockdowns to curtail the spread of the virus, the Government continues its vaccination programme. A little over 38,000 Jamaicans have been vaccinated since March 10. In week three, which ended on Tuesday, only 42 per cent, or 8,168 persons, had been vaccinated.
Dr Melody Ennis, who has responsibility for the country’s immunisation programme, noted that some persons have reported reactions which they feel could be linked to the vaccines.
“We have collected just about 40 of those. Most of the persons reported having the expected side effects of the vaccines, which include the flu-like illness, the real feeling of being tired, some amount of headache, and dizziness,” she said, adding that two persons were hospitalised due to allergic reactions.
Chair of the private-sector vaccine initiative Chris Zacca said that $14 million has been donated in cash and kind towards the vaccination effort. The health ministry signed a memorandum of understanding with several private-sector stakeholders last month to accelerate the procurement of COVID-19 vaccines.