President Trump press conference: Emergency Use Authorisation for Covid-19 convalescent plasma
Trump press conference on convalescent plasma to treat Covid-19
President Donald Trump announces FDA decision to approve Emergency Use Authorisation for convalescent plasma to treat Covid-19
In a press conference held on Sunday evening, alongside Alex Azar, Secretary for US Health and Human Services, and Stephan Hahn, the head of the Food and Drug Administration, President Donald Trump announced that the FDA has issued an Emergency Use Authorisation (EUA) for convalescent plasma to treat patients who are sick with Covid-19.
The idea behind the treatment is to take blood plasma from a patient who has recovered from Covid-19 and inject it into a patient suffering from the disease in the hope that antibodies from the recovered patient can help the ill patient recover. It is a treatment that has been used for over 100 years, and had some success in the treatment of two other deadly coronaviruses, SARS and MERS.
The EUA comes on the back of observational studies carried out as part of the US's Operation Warp Speed to find vaccines and therapies to fight Covid-19. In the convalescent plasma programme over 60,000 people were treated with the plasma.
The FDA says that they saw sufficient evidence to show the treatment is safe and that it shows "promise" in treating patients suffering from Covid-19, with what they claim is a 35% drop in mortality (for patients under 80 and who were not on a respirator). These figures have not been peer reviewed, nor was the study of sufficient scientific quality to prove that convalescent plasma actually works as effectively as theorised. Further studies will be required to prove the efficacy of the treatment. The FDA said the early evidence shows that plasma can reduce mortality and improve patients' health if administered in the first three days of hospitalisation.
The announcement comes on the eve of the Republican National Convention, where Trump will be nominated for the Presidential Elections in November. On Saturday, Trump tagged FDA Commissioner, Stephen Hahn, in a tweet and said "The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics." "Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!" Hahn said Trump had not spoken to him or the agency and did not play a role in its decision to make the announcement on Sunday.
And the conference ends, after a question Trump clearly didn't like, about whether convalescent plasma treatment is "extremely promising" or "highly effective" - it was described in both such terms in the conference.
The two different ways of describing the treatment arise because the observational studies that have led to convalescent plasma receiving an Emergency Use Authorisation are nowhere near gold-standard double blind trials with peer review, which would likely be needed for full approval, hence the treatment can only be referred to in scientific terms as "extremely promising". However, the FDA are saying that in these observational studies they have seen convalescent plasma being "highly effective", with what they say is a 35% reduction in mortality. It's going to be fascinating to see how they reached that 35% figure, because that would clearly be a major breakthrough. The problem with observational studies is that they are open to bias, cherry-picking of numbers and a host of other issues, which is why drug approval is not carried out using them.
Almost 100,000 people have been enrolled in the convalescent plasma programme, with 70,000 having received the treatment. Expert scientists at FDA have reached a decision that convalescent plasma is safe and shows "promise" in being a treatment, leading to the FDA issuing the Emergency Use Authorisation.
Trump urging people who have recovered from Covid-19 to donate blood - which is where the plasma comes from.
Andy Slavitt, who was head of head of health care under Obama, has a fascinating thread here on the situation with convalescent plasma (CP). According to his sources the trials on plasma have not been done well and that the the results of the study are unreliable (although there may well be some marginal benefit from the treatment).
According to Slavitt, there's no need for an EUA right now as CP is already in use and real clinical trials are being run in England. So why the announcement? Simply because Republican National Convention starts tomorrow.
Trump says convalescent plasma has had an incredible rate of success, reducing mortality by 35%. It will be interesting if they can produce the evidence to show that.
Confirmed, the FDA has issued a Emergency Use Authorisation for convalescent plasma.
Trump is widely expected to make an announcement concerning an Emergency Use Authorisation (EUA) for convalescent plasma as a treatment for Covid-19.
Convalescent plasma is an old idea, which has been around since the start of the 20th century, though it's been refined since then. The basic concept is to take blood plasma from a patient who has recovered from the illness and inject it into someone suffering from the disease in the hope the antibodies in the plasma from the recovered patient can help fight off the infection in the ill patient.
The treatment has been tried with some success in the treatment of two other deadly coronaviruses, MERS and SARS, and has also been used to treat influenza and Ebola.
An EUA does not require as much evidence as full approval. So far the FDA has allowed doctors to try convalescent plasma on an experimental basis to ascertain the results it could have, with some 60,000 patients having been given the treatment.
So far the evidence does not appear clear cut, with the Mayo Clinic stating on their website only that it "may be helpful for people with Covid-19 who aren't helped by other treatments"
Trump going to talk about California wildfires before he discusses the breakthrough in the fight against the 'China virus'.
That term is of course racist and the World Health Organisation specifically says not to use it, as it causes prejudice and a series of other problems, including attacks on ethnic groups and people not seeking treatment.
Hello and welcome to our live coverage of Trump's announcement on what the White House are calling a 'breakthrough' treatment for Covid-19.
White House Press Secretary Kayleigh McEnany said that Trump will hold a press conference to discuss a "major therapeutic breakthrough" for Covid-19.
Also in attendance at the press conference will be Alex Azar, Secretary for US Health and Human Services, Stephan Hahn, the head of the Food and Drug Administration.