Concepcion: Huge benefits outweigh risk on AstraZeneca vaccine

MANILA-– Following the reports from various European medical agencies on the currently being examined linkage of blood clotting with AstraZeneca vaccine and with the Department of Health and Food and Drugs Administration deciding to temporarily suspend AstraZeneca vaccination for persons below 60, Presidential Adviser for Entrepreneur and Go Negosyo Founder, Joey Concepcion, said Thursday that focus should instead be on the huge benefits of the AstraZeneca vaccine versus the risk.

“Of course any information like this is a point of concern. Most especially, we are expecting around 22 to 26 million total combined doses of AstraZeneca from the COVAX facility, LGUs, and private sector procurement. Also, most of the workforce in the private sector belongs to the age group below 60, same with the LGUs and other sectors, so this greatly affects our population. Vaccinating these sectors is very vital for the goal of our vaccination program, and failing to meet these goals might have a direct hit on the economy,” Concepcion noted.

“As of the moment, the Philippines has inoculated more than 500,000 individuals using the same vaccines. And if there are any extreme adverse effects, we should know it by now. Also, countries like Australia, Brazil, Mexico, Malaysia, Vietnam, Taiwan, Thailand, and many others have no restrictions except the UK which restricts ages below 30,” Concepcion added.

“Patient safety remains to be the highest priority for AstraZeneca. Tens of millions of people have now received our vaccine across the globe. The extensive body of data from two large clinical datasets and real-world evidence demonstrate its effectiveness, reaffirming the role the vaccine can play during this public health crisis. We will continue to work with the Philippine FDA to answer any questions they may have,” AstraZeneca  said in their statement.

“Aside from the assurance that AstraZeneca gave us, publications from medical experts suggest that the AstraZeneca vaccine is still extremely effective and safe despite blood (clotting) concerns. All experts agree that vaccination of AstraZeneca continues to be a huge benefit to our vaccination campaign and the current cases of very rare blood clots are still within the risk parameters. The number is very clear. With the March 31 data from the UK, from the 20.2 million recipients of the AstraZeneca vaccine, only 79 reported to have clotting issues—0.0000039%, or around 4 in every 1 million people that would receive the vaccine,” Concepcion explained.

“WHO is carefully monitoring the rollout of all COVID-19 vaccines and will continue to work closely with countries to manage potential risks, and to use science and data to drive response and recommendations. In extensive vaccination campaigns, it is normal for countries to identify potential adverse events following immunization. This does not necessarily mean that the events are linked to vaccination itself, but they must be investigated to ensure that any safety concerns are addressed quickly. Vaccines, like all medicines, can have side effects. The administration of vaccines is based on a risk versus benefit analysis,” WHO stated.

“The benefits of vaccination continue to outweigh any risks but the MHRA advises careful consideration be given to people who are at higher risk of specific types of blood clots because of their medical condition. The MHRA is not recommending age restrictions in COVID-19 vaccine AstraZeneca use,” MHRA forwarded.

“No effective medicine or vaccine is without risk. We continually monitor safety during widespread use of any vaccine. This is to ensure vaccines are performing as expected, to identify any new side effects that may arise, and to ensure the benefits continue to outweigh the risks,” Dr. June Raine, MHRA Chief Executive, said.

Adding to the confidence of the public, “We have a rich source of data–the best data there is–and the MHRA and CHM will continue to keep this under close observation. The public deserve nothing less,” Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicine, stated.

“The public’s safety is always at the forefront of our minds and we take every report of a suspected side effect very seriously indeed. We thoroughly analyze each and every report as we receive it and although the number of reports of CVST and other thromboembolic events has increased over the last week, so has the overall number of vaccinations administered, therefore these blood clots remain extremely rare and unlikely to occur,” Dr. Raine added.

With the update on the AstraZeneca vaccines, the 2.6 million doses procured by the first batch of donors are expected to arrive this May and June, no delays are expected as these doses would come from Thailand. For the second batch, the 14.5 million doses, procured by both the private sector and the LGUs, is expected to arrive towards the 3rd and 4th quarter.

“We are expecting all of these with no delays as we need to vaccinate the country as fast as we can. All of the vaccines are proven safe and effective before they are approved by numerous regulatory bodies. We need everyone to be vaccinated as this is the only way to win this war against COVID-19. In winning this war, we could open the economy and we will be able to save both lives and livelihoods in the process,” Concepcion stressed.