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COVID-19 | The Ministry of Health appears in the dark about the details of a reported donation of 500,000 doses of a Covid-19 vaccine candidate from the United Arab Emirates to be tested in Malaysia.
When asked about the donation today, Health Director Dr Noor Hisham Abdullah said he had “heard” about it, but called it “rumors.”
This is because documents on the candidate vaccine have not yet been submitted to the National Drug Regulatory Agency (NPRA) for review.
“We found out about the donation (where) around 500,000 vaccines will be donated to our country.
“But more importantly, it has to go through the NPRA registration (process). Once we get the registration, we will only allow the vaccine to be used in this country, ”Hisham responded during a press conference in Putrajaya tonight.
Government News Cable Called previously reported that the UAE government intends to donate half a million doses of vaccines for third-phase clinical trials in Malaysia.
Yang di-Pertuan Agong Sultan Abdullah Sultan Ahmad Shah (above) is currently on a special visit to the United Arab Emirates at the invitation of the Crown Prince of Abu Dhabi, Mohamed Zayed Al Nahyan, reportedly to discuss the donation.
Hisham assumed that the donated vaccines were “most likely” from China, but could not confirm when asked who the manufacturer of the vaccine was.
“That is why we are waiting for the complete document […] now it’s a rumor rather than a confirmation, “he said.
“Nothing has been sent to the NPRA at the moment,” the senior official replied when asked if the ministry was aware of exactly what vaccine the UAE intended to donate.
Hisham repeatedly emphasized that any vaccine must first be screened by NPRA no matter how it is obtained.
“Although the acquisition is from the UAE with China […] they will need to designate a company to facilitate registration in our country. Once you are registered, the NPRA will monitor you for the safety and efficacy of the vaccine, ”he said.
The UAE has not developed any Covid-19 vaccine of its own, but is currently conducting efficacy trials for two Covid-19 vaccine candidates.
A candidate is developed by the Gamaleya Research Institute of Russia (above), while the other candidate is a collaboration between Sinopharm and the Wuhan Institute of Biological Products.
Malaysia currently hosts one Covid-19 vaccine trial, which uses an experimental vaccine from the Institute of Medical Biology of the Chinese Academy of Medical Sciences (IMBCAMS).
The trial is being carried out in eight public hospitals and will have the participation of 3,000 participants.
The drugs to be used in clinical trials are generally provided by the trial sponsor, usually a pharmaceutical company that developed the drug.
Four months to evaluate the Pfizer vaccine
Meanwhile, Hisham confirmed that the ministry received a request from the US pharmaceutical company Pfizer on December 15 to register its Covid-19 vaccine with the NPRA.
Expect the agency to take up to four months to consider the request.
“We expect the correspondence with the company to begin at the end of this month (December 2020). NPRA has also identified 11 medical experts in relevant fields to review documents submitted to the ministry.
“We could take between 90 and 120 days, but we will prioritize access to the safety and efficacy of the vaccine,” he said.
The Malaysian government previously signed an agreement to acquire 12.9 million doses of Pfizer’s vaccine, which will be enough to vaccinate 20 percent of the population.
Malaysia has also signed an agreement to obtain vaccines for 10 percent of the population through the Covid-19 Vaccine Global Access (Covax) plan, and is scheduled to sign an agreement with the UK company. AstraZeneca today to cover another 20 percent.
China agreed to give Malaysia priority access to vaccines developed by the country, while Malaysia is still negotiating deals to ensure there are enough Covid-19 vaccines for at least 70 percent of the population.
