Thread by @kakape

"The committee has come to a clear scientific conclusion: This is a safe and effective vaccine. Its benefits in protecting people from #COVID19 with the associated risks of death and hospitalization outweigh the possible risks”, says Emer Cooke at @EMA_News press conference.

@EMA_News "The committee also concluded that the vaccine is not associated with an increase in the overall risk of thrombo embolic events or blood clots”, says Cooke.

@EMA_News "During the investigation and review we began to see a small number of cases of rare and unusual but very serious clotting disorders, and this then triggered a more focused review based on the evidence available”, says Cooke.

@EMA_News “After days of in-depth analysis of lab results, clinical reports, autopsy reports and other information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine”, says Cooke.

@EMA_News “What the committee has therefore recommended is to raise awareness of these possible risks making sure that they're included in the product information, drawing attention to these possible rare conditions”, says Cooke.

@EMA_News "We're also launching additional investigations to understand more about these rare cases, and we're conducting targeted observational studies”, says Cooke.

@EMA_News "I want to reiterate that our scientific position is that this vaccine is a safe, an effective option to protect citizens against #COVID19”, says Cooke.

@EMA_News "We're very much aware that some member states have paused vaccinations, waiting for EMA's outcome of a review”, says Cooke. “But given that 1000s of people in the EU die every day. … it really was crucial for EMA to review rapidly and thoroughly all the available evidence."

@EMA_News “This vaccine is safe and effective in preventing #COVID19 and its benefits continue to be far greater than its risks. PRAC has found no evidence of a quality or a batch issue”, says Sabine Straus, chair of EMA's safety committee (PRAC).

@EMA_News “PRAC has concluded that there was no increase in the overall risk of blood clots”, says Straus. “Moreover, because the vaccine is effective in preventing #COVID19 disease, which in itself, of course, is a cause of blood clots, it likely reduces the risk of thrombotic events."

@EMA_News “However, there are also still some uncertainties”, says Straus. "We have seen some very rare case reports, describing specific unusual events of a combination of thrombosis and thrombocytopenia and bleeding.” Mentions disseminated intravascular coagulation (DIC) and CVTs.

@EMA_News “The evidence we have is, at the moment, not sufficient to conclude with certainty whether these adverse events are indeed caused by the vaccine or not”, says Straus . "So PRAC will continue to gather more information on these conditions, including additional studies…"

@EMA_News “PRAC also concluded that it's very important that these events are rare”, says Straus. "As of last night, seven cases of this disseminated intravascular coagulation and 18 cases of cerebral venous sinus thrombosis were reported out of almost 20 million vaccinated people."

@EMA_News “PRAC has recommended to add a warning to the SMPC and the patient leaflets and the description of these cases, so that this information should be provided to healthcare professionals and to the public”, says Straus.

@EMA_News "EMA and national health authorities will ensure that health care professionals and the general public are made aware of this information and made aware of the signs and symptoms of concern so that timely action can be taken to mitigate these risks”, says Straus.

@EMA_News EMA also just sent out a press release with this information for patients:

@EMA_News So seek prompt medical assistance if you get any of these after vaccination:
- breathlessness
- pain in the chest or stomach
- swelling or coldness in an arm or leg
- severe or worsening headache or blurred vision after vaccination
- persistent bleeding
- multiple small bruises