Latest stats on adverse events released

The Covid AstraZeneca jab has been suspended in some countries as TGA releases latest Pfizer data

Since the roll-out of COVID-19 vaccines commenced on 22 February 2021 in Australia, about 86,400 doses of the Pfizer/BioNTech (Comirnaty) vaccine have been administered.

According to the TGA’s latest safety report, there have been 327 total reports of adverse events following immunisation received up to 7 March.

This equates to a reporting rate of 3.8 adverse events per 1000 doses.

In the past week (1-7 March), the TGA received a total of 253 AEFI reports for COVID-19 vaccines.

The most common adverse events reported during this period were headache, nausea, injection site reaction, dizziness and fatigue.

There was a small number of adverse events of special interest reported for the vaccine, with one report of stroke, and one report of facial weakness.

“A small number of people in clinical trials of Comirnaty experienced facial weakness,” said the TGA.

“Stroke is being monitored because of a theoretical link with COVID-19 disease.

“Our review does not suggest an increased risk of stroke, facial weakness or any other adverse event of special interest associated with the vaccine.

“Safety data collected on the COVID-19 vaccines used in Australia is consistent with the known side effects. No new safety concerns have been identified.”

AZ jab being investigated

Meanwhile Denmark, Norway and Iceland have temporarily suspended the use of the COVID-19 AstraZeneca vaccine.

This was decided as a precautionary measure while a full investigation is ongoing into reports of blood clots in people who received the vaccine, including one case in Denmark where a person died.

In Austria, one batch of the vaccine was suspended after a person was diagnosed with multiple thrombosis and died 10 days after vaccination, and another was hospitalised with pulmonary embolism after being vaccinated. The latter is now recovering.

As of 9 March 2021, two other reports of thromboembolic event cases had been received for this batch, the European Medicines Agency (EMA) confirmed.

The batch was delivered to 17 EU countries and comprised one million doses of the vaccine.

Italy also said it would suspend the use of a different batch of the AstraZeneca vaccine following the deaths of two men in Sicily, also as a precaution, according to Italian medicines agency AIFA.

However on Thursday, the EMA stated there is currently no indication that vaccination has caused thromboembolic events.

The vaccine’s benefits continue to outweigh its risks, said the EMA, and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing.

“The number of thromboembolic events in vaccinated people is no higher than the number seen in the general population,” said the EMA.

“As of 10 March 2021, 30 cases of thromboembolic events had been reported among close to 5 million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area.”

The EMA said its safety committee is already reviewing all cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination with the AstraZeneca vaccine.

The AstraZeneca vaccine was approved for use in Australia last month and the first group of Australians began receiving the vaccine this month.

Health Minister Greg Hunt received his COVID-19 jab on Sunday 7 March, at the official launch of the AstraZeneca vaccine.

He then took sick leave to battle cellulitis, a bacterial infection of his leg, with Prime Minister Scott Morrison stepping in as acting Health Minister.

Mr Morrison said there was no advice to pause Australia’s rollout.

“The TGA obviously looks at these reports when they come through, but they do their own batch testing as I [saw] visiting just this week,” he said on Friday.

He added that there are around 300,000 AstraZeneca doses already being distributed and a further 400,000 about to go out.

Mr Hunt was discharged from hospital on Saturday 13 March, and is expected to return to Parliament on Monday while continuing to be treated with antibiotics.

Data from the UK

Meanwhile the COVID Symptom Study has shared its findings. The not-for-profit initiative, launched by health science company ZOE with scientific analysis provided by King’s College London, has been tracking reported symptoms in app users across the UK.

As well as asking people to log daily reports about their general health for a week after vaccination, which captures systemic effects, they have also asked about local effects. 

Since the Pfizer/BioNTech COVID-19 vaccine began rollout in the UK on 8 December, millions of people have been vaccinated, including the elderly, care workers and frontline NHS staff.

The COVID Symptom Study data team has analysed reports from nearly 40,000 people who were vaccinated in December: 23,308 people who had received just one dose, and 12,444 who had both.

They found around one in seven people who received one dose of the vaccine experienced at least one systemic effect within seven days of their jab.

Around four in 10 people who received their first dose had at least one after effect in their arm, most commonly pain and swelling in the day or two after the jab.

Most symptoms happened in the first two days after vaccination, with headache, fatigue and chills or shivers being the most common.

After effects were more common the second time around, with around one in five who received their second dose of the Pfizer vaccine logging at least one systemic effect.

Similarly, more people experienced effects in their arm after their second dose, with about half reporting local symptoms like pain and swelling.

Source: COVID Symptom Study

“We found that previous exposure to coronavirus makes it more likely that someone will experience systemic effects after vaccination,” said the study team.

“Around a third of vaccinated people who had COVID-19 in the past reported at least one systemic effect within seven days from their vaccination, compared with just under one in five people who had not already had the virus,” they said.

“Around one in 20 people who had previously had COVID-19 experienced after effects for more than three days during the first week, and around one in fifty were affected for six days or more.”

Data from the US

Over 92 million doses of COVID-19 vaccines were administered in the United States between 14 December 2020 and 8 March 2021.

During this time, the country’s Vaccine Adverse Event Reporting System (VAERS) received 1,637 reports of death (0.0018%) among people who received a COVID-19 vaccine.

According to the Centers for Disease Control and Prevention (CDC), a review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths.

“To date, VAERS has not detected patterns in cause of death that would indicate a safety problem with COVID-19 vaccines,” said the CDC.

Anaphylaxis after COVID-19 vaccination is considered rare and occurred in approximately 2-5 people per million vaccinated in the US, based on events reported to VAERS.

Currently, three COVID-19 vaccines are authorised in the US: the Pfizer-BioNTech vaccine, the Moderna vaccine, and one from Johnson & Johnson / Janssen.

This article was updated on 15 March to include further details on Minister Hunt’s health and return to Parliament.

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