AstraZeneca offers strong assurance on safety of its COVID-19 vaccine

* Based on clear scientific evidence from more than 17 million people vaccinated in the EU

* This follows recent concerns raised around blood clotting through social media

* “The nature of the pandemic has led to increased attention in individual cases”

* “We are going beyond the standard practices for safety monitoring”

By Duncan Mlanjira

There are unfounded reports circulating through social media across the world including Malawi that are purporting that the AstraZeneca COVID-19 vaccine which is also being administered in Malawi but AstraZeneca has released a statement of assurance of their vaccine’s safety.

AstraZeneca says “safety is of paramount importance and the company is continually monitoring the safety of its vaccine based on clear scientific evidence”.

It says after a careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZenecahas shown no evidence of an increased risk of pulmonary embolism — a condition in which one or more arteries in the lungs become blocked by a blood clot.

Medically, a pulmonary embolism is caused by blood clots that travel from the legs, or rarely, other parts of the body (deep vein thrombosis or DVT) and AstraZeneca says its review of the vaccine also does now show any evidence of an increased risk of DVT or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

 

“So far across the  EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March,” says the statement issued on Sunday, March 14.

“This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.

“The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.”

AstraZeneca further says from the clinical trials done, even though the number of thrombotic events was small, these were lower in the vaccinated group and “there has also been no evidence of increased bleeding in over 60,000 participants enrolled”.

The producers quote Dr. Ann Taylor — AstraZeneca’s Chief Medical Officer — as saying “the nature of the pandemic has led to increased attention in individual cases” as has most of the reports on social media can attest.

“We are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” Ann Taylor is quoted as saying.

She also added credence that from the 17 million people in the EU and UK that have now received their vaccine, “the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population”.

The company further says in terms of quality, there are also no confirmed issues related to any batch of its vaccine used across Europe, or the rest of the world.

“Additional testing has, and is, being conducted by ourselves and independently by European health authorities and none of these re-tests have shown cause for concern.

“During the production of the vaccine more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories.

“All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries.

“The safety of the public will always come first. The Company is keeping this issue under close review but available evidence does not confirm that the vaccine is the cause.

“To overcome the pandemic, it is important that people get vaccinated when invited to do so.”

When President Lazarus Chakwera and his Vice-President Saulos Chilima were launching the national roll out of the vaccination last Thursday, they both assured the public that AstraZeneca vaccine was safe as assured by relevant global authorities — including the World Health Organisation (WHO).

Several high ranking government officials, including former Head of State, Bakili Muluzi have come forward to have their vaccine — a seal of approval for the public to get vaccinated when invited to do so after healthcare workers in the frontline battle of the pandemic and other officials from essential service providers.

In its statement, AstraZeneca said its vaccine was co-invented by the University of Oxford and its spin-out company, Vaccitech.

“It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

“After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

“The vaccine has been granted a conditional marketing authorisation or emergency use in more than 70 countries across six continents — and with the recent Emergency Use Listing granted by the World Health Organization — it accelerates the pathway to access in up to 142 countries through the COVAX Facility.”

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas — Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

The public is encouraged to find out more of the company by visiting astrazeneca.com or follow on Twitter @AstraZeneca.