FDA allows open label extension for leronlimab at hospitals that were running the just filled phase 3 CD12 leronlimab trial for severe/crititcal Covid patients. EIND leronlimab treatment available elsewhere. Awaiting highly anticipated results of the CD12 trial in coming weeks.
On 30 December the four UK chief medical officers announced that the second doses of the covid vaccines should be given towards the end of 12 weeks rather than in the previously recommended 3-4 weeks.
The BMA has called the government’s decision “unreasonable and totally unfair” and said it could cause “huge logistical problems” for general practices and vaccination centres. GPs and clinical leaders have told the BMA that delaying already promised second doses “will have a terrible impact on the emotional wellbeing of their most vulnerable, at-risk patients.”
The US news site STAT referred to the move as “effectively turning [the UK] into a living laboratory.” It accused the UK of basing its new vaccination schedule “on small slices of evidence mined from ‘subsets of subsets’ of participants in clinical trials . . . and on general principles of vaccinology rather than on actual research into the specific vaccines being used.” It added, “If the efforts succeed, the world will have learnt a great deal. If they fail, the world will also have gained important information, though some fear it could come at a high cost.”
Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine
January 13, 2021 -- Interim Phase 1/2a data were published today in the New England Journal of Medicine demonstrating that the Company’s single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) – being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson – provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. A preview of part of these interim data was posted on medRxiv in September 2020.
The Phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants. Data demonstrated that, after a single vaccination, neutralizing antibodies against COVID-19 were detected in over 90 percent of study participants at Day 29 and 100 percent of participants aged 18-55 years at Day 57. These neutralizing antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years. Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.
This one shot vaccine also has less stringent storage and processing requirements for the already approved vaccines including the Oxford one. Much easier to dispense and reduces logistical requirements.
Depending on remaining trials and approval it may receive approval in a month or so. Outlook is excellent but timing on approval is still fuzzy.
Portion of link below and please note the Bold italic Part
A World Health Organization (WHO) team has arrived in the Chinese city of Wuhan to start its investigation into the origins of the Covid-19 pandemic.
The long-awaited probe comes after months of negotiations between the WHO and Beijing.
A group of 10 scientists is set to interview people from research institutes, hospitals and the seafood market linked to the initial outbreak.Covid-19 was first detected in Wuhan in central China in late 2019.
The team's arrival on Thursday morning coincides with a resurgence of new coronavirus cases in the north of the country, while life in Wuhan is relatively back to normal.
They will undergo two weeks of quarantine before beginning their research, which will rely upon samples and evidence provided by Chinese officials.
Team leader Peter Ben Embarek told AFP news agency just before the trip that it "could be a very long journey before we get a full understanding of what happened".
This is completely laughable. In no way will this be a scientific investigation and in no way will it be independent as it should be. Any scientific investigation into the origin of COVID should free to go down any path the scientific method would dictate, the WHO team should be able to collect and analyze their own samples and investigate and interview people and officials and Chinese scientists and have complete and free access to all documentation, papers, and sampling histories and all related COVID data, for just a few examples. To think that this will produce much useful information is gloriously silly. It is useful propaganda for the Chinese and nothing more.
And I just barely touched on how laughable all this is. All the details would be too long to elucidate.
Last edited by Zeno; 01-19-2021 at 04:52 PM.
Oh goodie. The best part is these "vaccines" (not vaccines) have been approved by the most definitely independent regulator the MHRA. Check out the register of interest, all the big names present and correct. Quite a few knights of the British Empire, dames, CBEs etc.
It seems that DVT rates are about 1 in 1000 per year. Maybe less air travel helps but if 100M+ people have been vacinnated in the USA and no-one has had a blood clot then there's some sort of miracle going on*. Plus there must be loads of other deaths as ~250k people die a month in the usa.
It could be there was a cluster of blood clots after the vaccine which would be a genuine cause of alarm about the manufacturing process rather than the vaccine itself.
*also many people who have been vaccinated will also have either already have early stage covid or catch it after the vaccine. As blood clots are one of the problems caused by covid it seems fairly implausable there have been none.