ONCE hailed as a game-changer in the Covid-19 vaccine race, the AstraZeneca-Oxford vaccine has now found itself in a bind following incidents of a rare blood clot disorder among some recipients.

Malaysia is set to receive 600,000 doses of the vaccine in June.

But after adverse reports on the vaccine, especially among women, and with several countries stopping its use, Malaysia is now reviewing the findings of the European Medicines Agency (EMA).

Science, Technology and Innovation Minister Khairy Jamaluddin said last week the government will review the findings of the EMA to decide whether the vaccine should be administered to the Malaysian public.

The vaccine, developed by the Anglo-Swedish pharmaceutical firm AstraZeneca PLC and Oxford University, was not only affordable, but was said to be highly efficacious, earning the tag the game-changer.

Another advantage of the vaccine, which goes by the official name Vaxzevria, was that it could be easily stored, unlike some of the other vaccines.

However, there has been increased public scrutiny after a series of controversies, especially over safety.

Controversy started over supply issues earlier this year when the European Union complained of delayed delivery to member states.

Another controversy emerged when many countries, including France and Germany temporarily suspended its use, for fear it was unsafe for senior citizens above the age of 65. The countries also cited the lack of data.

French President Emmanuel Macron described the AstraZeneca jab as “quasi-ineffective for people over 65”, merely hours before it was approved by the EMA.

Media reports stated stocks of the vaccines were going unused in both countries. This went on despite the EMA recommending the use of the vaccine on the elderly.

AstraZeneca then came out to allay concerns, saying there are studies to prove its efficacy among seniors.

The vaccine was once again shoved into the limelight, this time for more serious reasons, when a few cases of blood clot and deaths were reported among recipients.

Questions on its safety intensified and countries became wary and began halting its use to investigate links between the cases and the vaccine.

By early April, EMA received 169 cases of the rare brain blood clot after 34 million doses had been administered. Most of these cases reportedly occurred in women under 60.

The UK’s Medicines and Healthcare products regulatory agency itself received 30 reports as of March 24, which included 22 reports of cerebral venous sinus thrombosis (blood clotting in the veins that drain blood from the brain), and eight linked to thrombosis events with low platelets.

This was out of the 18 million doses administered in the country until March 24.

“Out of the 30 reports up to and including March 24, seven recipients have died,” AstraZeneca said in a statement.

However, the agency said the benefits of the vaccine “outweighed the risk”. Rigorous review was also being conducted by the regulator on the vaccine.

The EMA acknowledged on April 7 of a possible link between the occurrence of unusual blood clot with low blood platelets. This, however, was reportedly a very rare side effect of Vaxzevria.

“The chance of having this occur is very low, but you should still be aware of symptoms so you can get prompt medical treatment to help recovery and avoid complications,” the EMA said.

Covid-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing Covid-19 outweigh the risks of side effects, it added.

It urged recipients to seek urgent medical attention if they experience any of the following symptoms, including shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms, such as severe and persistent headaches or blurred vision and tiny blood spots under the skin beyond the site of the injection.

Denmark became the first country to completely stop the use of the vaccine altogether.

Danish health officials said on April 14 that it will withdraw all 2.4 million doses of the AstraZeneca vaccine until further notice.

The country’s health authorities said studies had shown a higher-than-expected frequency of blood clots in recipients of the jab, affecting about one in 40,000 people. – April 16, 2021.