Vaccine side effects

EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU

https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-janssen-authorisation-eu

Janssen should start delivering vaccines by April, and significant amounts by May

https://nos.nl/artikel/2372206-vierde-coronavaccin-goedgekeurd-voor-eu-janssen-krijgt-positief-oordeel.html

Recommended conditional marketing authorisation, 18 years +

Concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality

4th vaccine now for EU, first single dose

Phase 3

N = over 44,000

RCT

Half and half

67% reduction in the number of symptomatic cases after 2 weeks

US efficacy data

72% effective in preventing moderate illness

85% effective at protecting against severe cases

100% effective in preventing hospitalization and death after one month

Side effects

Usually mild or moderate

Cleared within a couple of days

Pain at the injection site, headache, tiredness, muscle pain and nausea

Pharmacovigilance will continue

UK

Ordered 30 million J and J

Denmark

14 day halt in use of the Oxford-AstraZeneca vaccine

Blood clots, and one death

Health Minister Magnus Heunicke

precautionary measure

we must respond in a timely and careful manner

Austria

One woman (49) died 10 days after vaccination

Estonia, Latvia, Lithuania, Luxemburg have also stopped using the batch

EMA

Probably 3 cases and one death

One million doses in batch

Safety committee was reviewing the Austrian case

there is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine

thromboembolic events in vaccinated people is no higher than that seen in the general population

22 cases of thromboembolic events, three million people vaccinated with AstraZeneca vaccine in the European Economic Area

Authorised 29th January

Epidemiology of venous thromboembolism

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4624298/

Incidence rate

Men, 130 per 100,000 per year

Women, 110 per 100,000 per year

That’s 10 per month per 100,000

That’s 120 per million per month

Therefore for 3 million of the population 360 thromboembolic events expected per month

Czech Republic

Sent first patients to Poland

Hungary

Cases higher than in December

Poland

Cases highest since late November

increased looseness among Poles towards anti-Covid measures

Brazil

Population 214 million

https://www.bbc.co.uk/news/world-latin-america-56355861

Cases, 79,876

Deaths, + 2,000 = 270,656

Second highest death numbers

Margareth Dalcolmo, doctor and researcher at Fiocruz

the worst moment of the pandemic in Brazil

overload and even collapse of health systems

Dr Pedro Hallal, Epidemiologist

If we do not start vaccinating the population here very soon, it will become a massive tragedy

It took a long time for the politicians to act

P.1

Could be up to twice as transmittable as the original virus

Chance of reinfection, 25% to 60%

Brazil, natural laboratory, when coronavirus goes relatively unchecked

Breeding ground for new variants, several VOCs circulating

Rapid vaccination and NPIs required

Vaccines remains efficacious, but probably slight reductions

Source