AstraZeneca Vaccine Safe – FDA

The Food and Drugs Authority has assured the Ghanaian public that the AstraZeneca vaccines are safe adding that no side effects have been recorded in Ghana yet.

Over 300, 000 Ghanaians have been given the jab after the country took delivery of some 600, 000 doses of the vaccines last month.

Fourteen European countries including 12 EU members have now suspended the use of the shots altogether – with Sweden joining the list today – while another five have black-listed specific batches and a handful of governments outside Europe have also pulled the emergency brake.

They said they were pausing the rollout following reports of blood clots in some recipients. Blood clots are solid clumps that form in the blood, which can be life-threatening if not treated quickly. The countries stressed that it was a precautionary measure.

The WHO says there is no evidence of a link between clots and vaccines.

It has urged countries not to pause their vaccinations.

The European Medicines Agency (EMA) – the European Union’s medicines regulator – is also meeting on Tuesday. It has previously said that people can continue receiving the vaccine.

AstraZeneca says a review of 17 million people who received doses in Europe found there were 37 cases of people who had developed blood clots.

Experts say the number of blood clots reported in vaccinated people is no higher than that seen in the general population.

In a statement, the FDA said its review of the vaccines indicated that it is safe for use and that since it started administering the drug no adverse effects have been recorded in the country.

The FDA added that it was working with health experts globally to continue to support the vaccine program and protect public health. The FDA assured the public to have confidence in the vaccine and continue taking it.

Below is the full statement by the FDA

On 26th February 2021, the Food and Drugs Authority constituted a Committee of Experts — the Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) — which meets bi-weekly to assess all reported adverse events and make recommendations on the safety of COVID-19 vaccines.

At its meeting held on 12th March 2021, the JCVSRC discussed reports received through the FDA’s robust safety monitoring system since vaccinations started. The most commonly reported adverse events are headaches, fever, chills, body pains, pain at the injection site, weakness, nausea, and dizziness.

These adverse events are expected from the vaccination and in most cases, resolved within a day or two. Additionally, the JCVSRC discussed reports of blood clots in some countries in Europe following vaccination with the AstraZeneca COVID-19 vaccine, leading to the suspension of vaccination for further investigations.

It concluded that there is currently no causal link between the event and the vaccine, a position that was subsequently upheld by the European Medicines Agency and the World Health Organization.

In view of the above, the FDA would like to reassure the public that it is closely monitoring this situation locally and to date, no events of blood clots linked to the Covishield vaccine have been reported among those who have been vaccinated in Ghana.

Generally, vaccines and medicines tend to have some side effects and this needs to be continually balanced against the expected benefits in preventing illnesses.

The Authority continues to work with its Committee of Experts, other regulators globally and will use its established safety monitoring system to support the vaccine program to ensure public health and safety.

A weekly safety will be made public on the FDA website: www.fdaghana.gov.gh For any vaccine safety-related information or to report side effects of COVID-19 vaccines, please contact the FDA through the following: Mobile: 024 4310 297 Email: drug.safety©fdagov.gh Hotlines:055 1112 224/ 055 1112 225 Online: http://adr.fdaghana.gov.ghipatient.php WhatsApp: 055 1112 225 Med Safety App: Med Safety App —apple store/play store. FDA… Your Well-being Our Priority.