– Dr. Anthony says global authorities will flag unsafe vaccines

COUNTRIES which paused the rollout of the AstraZeneca vaccines amid concerns of an increased risk of blood clots in vaccinated persons have signalled a cautious resumption of the vaccination rollout after the World Health Organization (WHO) and European Medicines Agency (EMA) found that there is not an increased overall risk of blood clotting disorders.

Numerous countries suspended the rollout of the AstraZeneca vaccines after 30 cases of rare blood clots were discovered out of a total of more than 20 million people who received the AstraZeneca vaccine in Europe. This led to investigations by the regulatory body which subsequently concluded that the vaccines do not result in an increased overall risk of blood clots and that the benefits of using the vaccines to prevent persons from getting the disease, COVID-19, outweigh the risks.

After a review by the WHO and EMA, Reuters reported that Germany, Italy and other countries, including Indonesia, restarted the vaccination rollout on Friday. However, France’s health regulator recommended that only persons over 55 should get AstraZeneca shots since many of the blood clot incidents were recorded in women under the age of 55.

“COVID-19 Vaccine AstraZeneca is not associated with an increased overall risk of blood clotting disorders. There have been very rare cases of unusual blood clots accompanied by low levels of blood platelets (components that help blood to clot) after vaccination,” the EMA said.

It is important to note, however, that the EMA acknowledged that the number of reported blood clot incidents exceeds those expected. Though it is not confirmed that this was caused by the vaccines, caution is advisable.

“However, given the rarity of the events, and the difficulty of establishing baseline incidence since COVID-19 itself is resulting in hospitalisations with thromboembolic (blood clot) complications, the strength of any association is uncertain,” the EMA said on Thursday.

The EMA has updated the product information of these AstraZeneca vaccines to reflect the caution for blood clot incidents. The EMA, reportedly, said a link between rare events of blood clots in the brain and the jab could not be definitively ruled out and it would continue its scrutiny. The British Medicines and Healthcare products Regulatory Agency (MHRA) will also continue to monitor and scrutinise even though no such incidents have been recorded in that country.

Meanwhile, the WHO urged countries to continue using this vaccine after reviewing clinical trial data and reports based on safety data from Europe, the United Kingdom, India, and Vigibase, along with the WHO global database of individual case safety reports.

“Reported rates of thromboembolic events after COVID-19 vaccines are in line with the expected number of diagnoses of these conditions,” the WHO said in a recent statement, emphasising: “Both conditions occur naturally and are not uncommon. They also occur as a result of COVID-19. The observed rates have been fewer than expected for such events.”

Guyana received 83,000 doses of the Oxford-AstraZeneca vaccine, produced by the Serum Institute in India. This vaccine is referred to as the ‘Covishield’ vaccine and has been donated by the Government of India to Guyana and several other Caribbean countries. It is important to note that the WHO has granted Emergency Use Authorisation (EUA) to two versions of the AstraZeneca/Oxford COVID-19 vaccine. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India. Caribbean countries have only received the AstraZeneca vaccine manufactured by the Indian company.

In a recent release, the Caribbean Public Health Agency (CARPHA) noted that the vaccine being used in the Caribbean is not the same version or batch as the one in Europe. It is unclear what the differences in the batches are. CARPHA, however, highlighted, “Adverse reactions that happen following immunisation with any vaccine need to be fully investigated to rule out various factors, for example concomitant illnesses, progression of a disease, and batch assessment, before a final decision is made by the health authorities.”

With the blood clots only being recorded in a small number of people, Guyana’s Minister of Health, Dr. Frank Anthony, assured [the Nation] that if there was an issue with the vaccine, the global regulatory authorities would flag the vaccine and ask countries to stop using it.

“Like anything else they will continue to monitor to see if there is anything that is coming up and to review those cases to see whether there is an association between vaccination and any disorder that will come up from time to time,” Dr. Anthony said on Friday, adding: “once they do that, and if there is a connection, obviously, they will publicise that and they’ll make sure that it is safe to use or if it is unsafe then they will say so and then you will stop the use.”

In the local context, he assured that Guyana’s vaccination rollout is being monitored by a pharmaco-vigilance committee.

“What we have found is that we haven’t had any case of extreme adverse reactions; however, we do have persons who would have side effects… these would normally go away within a 24 hour period,” the Health Minister noted. Common side effects including swelling and pain at the vaccination site, fever and headache. These have all been, reportedly, short lived.

On Friday last, the Health Minister announced that more than 15,000 persons had been vaccinated locally. These include frontline healthcare workers and elderly persons over the age of 60. Vaccination is ongoing in all 10 regions and it is expected that the next group of persons to receive these COVID-19 vaccines would be elderly persons over the age of 50.

In addition to the Covishield vaccines, Guyana is also using the Sinopharm vaccine from China to immunise persons. Shortly, Guyana is expected to receive more doses of the AstraZeneca vaccine from the COVAX facility, the global vaccine alliance for the equitable distribution of vaccines and the Sputnik V vaccines from Russia.