PAHO/WHO Representative DR Erica Wheeler

The COVAX Facility is still standing behind the AstraZeneca (AZ) vaccine even in the face of a multi-country suspension over concern of blood clots. To date, some 18 countries have suspended the use of the AstraZeneca vaccine over concerns of blood clots.

T&T is part of the COVAX Facility and received 33,600 AZ vaccines at the end of March. The country also received 40,000 doses from the Serum Institute of India, manufactured under the AstraZeneca label for local use.

Guardian Media reached out to GAVI, which is the vaccine alliance that distributes vaccines through the COVAX Facility. Guardian Media also reached out to the office of the Chief Executive Officer at the Serum Institute of India. His office directed all media questions to an Indian-based Public Relations company. They have not yet responded to questions.

On Thursday, though, a GAVI spokesman said that it has been following the global news but still believes that the AZ vaccine is “safe”.

“Ensuring safe and effective vaccines are provided to the most vulnerable around the world is the top priority for COVAX. Gavi along with its COVAX partners, including WHO (World Health Organisation), is closely following the news,” the spokesman said.

“Decisions on the COVAX portfolio that relate to safety as well as recommendations and guidance for use of vaccine products are based on WHO guidance.”

The spokesman added, “WHO guidance on the use of the AZ vaccine remains unchanged. As reiterated in statements by the European Medicines Agency as well as WHO’s Global Advisory Committee on Vaccine Safety (GVACS), the AstraZeneca vaccine remains an important public health tool against the COVID-19 pandemic and is effective at preventing severe cases, hospitalisation and death.”

The spokesman accepted that the “speed with which vaccines have been developed in this pandemic has been unprecedented” and acknowledged that the broad global rollout means that “other very rare side effects may be discovered.”

“That means this kind of careful monitoring is a critical component of emergency development and rollout, allowing the health care provider community to account for these very rare side effects in the administration of the vaccine, similar to the efforts that would be–and are–undertaken with any other therapeutic or vaccine,” the spokesman said.

GAVI said that this also re-emphasises the critical need to have a range of safe and effective vaccines available globally.

“Both the emergence of potentially significant safety signals and new variants underscores the importance of continued investment in R&D and maintaining a diverse portfolio of candidates and approaches to vaccine development–meaning vaccines are available that are appropriate for use in a wide range of contexts and settings,” the group said.

PAHO director defends vaccine safety for cardiac patients

Locally one cardiac patient passed away eight days after receiving the first AZ shot and while the family is blaming the vaccine for the blood clots that he developed that left him paralysed before his death, medical professionals have said that the vaccine was not to blame.

Similar questions are being raised after the sudden passing of Energy Minister Franklin Khan who received his COVID-19 vaccination at the Diego Martin Health Facility on Tuesday.

Khan, according to reports, seemed in good health in the days following the inoculation and his passing was described as sudden.

Khan also had a heart-related operation back in 2017 and underwent a “minor” procedure last year.

Director of the Pan American Health Organisation (PAHO) Dr Erica Wheeler also defended vaccine safety and its use for cardiac patients.

In a text exchange with Guardian Media on Friday and yesterday, Dr Wheeler said that there was no advisory for patients with heart issue against taking the vaccine.

“Because persons with underlying health conditions are more likely to become severely ill or die if they get COVID-19,” she said yesterday.

“However, the advice is always if in doubt, persons must consult their doctor. Their doctors know their medical history best.”

Asked if the vaccine was safe, Wheeler said the vaccine has been tested on thousands of people before it was rolled out to the public.

“Yes, the AZ vaccine is safe. It has been reviewed by WHO and has been reviewed for quality, safety and efficacy,” she said.

“The blood coagulation events are to date seen as rare. The evaluation of a vaccine goes through different phases (preclinical and clinical) until it receives regulatory approval. The process is to ensure a safe and effective vaccine.

“There are 3 phases of trials two to three. By the time the vaccine candidate reaches phase 3 of a clinical trial, it is tested on several thousands of people and this information is provided to WHO,” she said.

“This is the last phase before receiving regulatory approval by WHO.”

Dr Wheeler said that the WHO’s Global Advisory Committee on Vaccine Safety systematically reviews any vaccine safety signals and concerns related to COVID-19 and advises WHO on any new safety signals or concerns related to the vaccines.

“This Committee is carefully assessing the current reports related to the AZ vaccine. As soon as there is a full understanding of these events, the findings and any unlikely changes to current recommendations will be immediately communicated to the public,” she said.

Wheeler said that as of now “there is no evidence that the incidents are caused by the vaccine and therefore it is important that vaccination campaigns continue so that we can save lives and stop the severe disease from the virus.”

She said that as of March 12 over 300 million doses of COVID 19 vaccines have been administered since the start of the pandemic and no cases of death have been found to be caused by vaccines.

According to Dr Wheeler, before the pause, the AZ vaccine was given to more than 19 million people in the UK with no evidence of related serious adverse events.

“AZ manufacturers also said there were no issues with quality with any batch used across Europe. During the production of the vaccine, more than 60 quality tests were conducted by the manufacturer, its partners and more than 20 independent testing laboratories.

“All tests need to meet stringent criteria for quality control and these data are submitted to regulators for independent review before any batch is released,” she said.

Wheeler said that evidence from AstraZeneca has shown that a careful review of all available safety data of more than 17 million people vaccinated in the European Union and the UK “has shown no evidence of an increases risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, (blood clots) in any defined age group, gender, batch of vaccines or in any particular country.”

“Whether these rare events that are presumably linked to AZ and J&J which are still to be determined,” she said.

“The message is that the benefits still outweigh the risks because adverse events are very rare, while the risk of serious illness and death from COVID-19 is still high.”