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