Big news for Europe: @EMA_News now planning to meet on 21 December not 29 to conclude assessment of Pfizer/Biontech #covid19 vaccine and hopefully recommend conditional marketing authorisation.
@EMA_News "Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible”, says press statement they just e-mailed.
@EMA_News That means the timeline for vaccinations across Europe is likely moving up by about a week.
Not surprised to see this given growing chorus of voices in recent days asking why Europe is taking longer than UK/US.
@EMA_News 29 December was always mentioned as date “at the latest”. And it’s still a possibility, though very unlikely:
"The meeting planned for 29 December will be maintained if needed.” ema.europa.eu/en/news/update…
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#covid19 vaccines "will not be the magic bullet immediately”, says Emer Cooke, head of EMA. “For some time we will need to continue with social distancing and masks. There is no doubt about that.” But over time “we do hope that there will be a move to a more normal existence."
Cooke was answering questions from @EP_Environment. Says @EMA_News has "a very robust data set on which to make a decision, both on safety and efficacy” for the two mRNA vaccines. “The efficacy and safety looks very promising we have not seen adverse events coming up."
@EP_Environment@EMA_News "The information on the quality and manufacturing has come a little bit later”, says Cooke. "And that's also very complex, particularly because as has been pointed out, these are new types of vaccines, they require specialized expertise for us to examine that."
“Hundreds of seroprevalence studies have been done around the world, which vary in quality, methods and the type of tests used”, says @DrTedros at @WHO#covid19 presser. “They tell us that most of the world’s population remains susceptible to infection with the #covid19 virus"
@DrTedros@WHO "We are still learning how strong immune responses are in different populations and for how long this immune response lasts”, says @drtedros.
@DrTedros@WHO Who to prioritise in vaccination campaigns “are not easy decisions”, says @DrTedros. "Vaccinating health workers who are at high risk of infection will help to protect them and the health system.”
@pandemiapodcast The outbreak in Samoa started in October 2019. As usual there are multiple, complex reasons that all led to vaccine coverage declining. There was complacency, there were structural changes in the health care system, there were anti-vaccine groups. And there was a terrible tragedy
@pandemiapodcast In July 2018, two children died just after receiving the measles vaccine. Nurses preparing the vaccine had accidentally mixed the powder with an anaesthetic instead of water. (They were sentenced to 5 years in prison.)
The deaths further fuelled fears about vaccines.
“@WHO is concerned that there is a growing perception that the pandemic is over”, says @drtedros at #covid19 presser. "The truth is that at present, many places are witnessing very high transmission of the virus."
@WHO@DrTedros "We know it has been a hard year and people are tired, but in hospitals that are running at or over capacity it's the hardest it can possibly be”, says @DrTedros. "Please be careful. Think of health workers and act for the greater good, because it will save lives and livelihoods"
@WHO@DrTedros "The pandemic still has a long way to run and decisions made by leaders and citizens in the coming days will determine, both the course of the virus in the short term and when this pandemic will ultimately end”, says @drtedros. "Fighting this pandemic is everybody's business."
I don’t really remember how we marked the beginning of a new week in pre-pandemic times, but these days we celebrate “good news on vaccines” Mondays, followed by “not so good news on global #covid19" Tuesdays.
That’s to say: the WHO’s weekly sitrep is up. Quick thread
Big picture:
3,935,330 new cases and
69,916 new deaths
were reported to @WHO last week.
That means deaths have risen for a sixth week (+3%), but cases are down 4% from last week.
It is a huge amount of death and disease from one little pathogen.
@WHO Number of new #covid19 cases finally going down after two months of increases may sound great.
The problem is that the data includes the craziness of US Thanksgiving numbers.
US case number is basically the same as last week, when it should probably be a lot higher.
Here we go. Moderna and Biontech/Pfizer have today submitted the data on their #covid19 vaccines to the EMA to request a conditional market authorisation. EMA spokesperson told me they think a decision could come “by the end of this year at the earliest”.
If data submitted on Biontech vaccine is robust enough, “EMA’s scientific committee for human medicines (CHMP) will conclude its assessment during an extraordinary meeting scheduled for 29 December at the latest”
If data on Moderna vaccine is robust “EMA’s scientific committee for human medicines (CHMP) will conclude its assessment during an extraordinary meeting scheduled for 12 January at the latest”.