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J&J vaccine trial hits pause as US doubles down on antibody therapies

Johnson & Johnson (JNJ) announced late Monday it was pausing shots in its late-stage coronavirus vaccine trial due to an adverse event, but plans to continue enrolling patients and stick to the current manufacturing timeline.

It is still unknown if the participant was receiving a placebo or the vaccine, a point that will be determined by an independent advisory group, known as the Data Safety Monitoring Board (DSMB). Another vaccine using similar technology from AstraZeneca (AZN) is still on hold after a serious adverse event from a trial participant triggered a halt in September. The trial has continued in the U.K., but remains on hold in the U.S.

“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies,” J&J said statement late Monday, reiterating that “studies may be paused if an unexpected serious adverse event (SAE)” occurs that may or may not be related to the trials. The company promised a “careful review of all of the medical information before deciding whether to restart the study.”

Mathai Mammen, head of research and development at Janssen, J&J’s pharmaceutical arm, said the information is kept confidential from the company until the DSMB reviews it.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during an investor call Tuesday.

The two frontrunner candidates in the U.S., Moderna (MRNA) and Pfizer (PFE) with BioNTech (BNTX), are using technology that has never been approved, but have so far not hit any significant adverse events.

Meanwhilel, Pfizer’s non-peer-reviewed data showed some side effects, but nothing that would trigger a halt. Pain at the point of injection and fatigue are considered normal vaccine side effects — seen frequently after flu shots.

Monoclonal antibodies

There are over 7.6 million cases in the U.S. (Graphic: David Foster/Yahoo Finance)
There are over 7.6 million cases in the U.S. (Graphic: David Foster/Yahoo Finance)

The experimental treatment used by President Donald Trump while he was at Walter Reed Military Medical Center is gaining momentum as the country awaits a vaccine by the end of the year.

Monoclonal antibody treatments, which are lab-produced antibodies from a sample of recovered patients, has been seen as a bridge between standard treatments and a vaccine, as well as an alternative for those who cannot be given a vaccine. That is because it can both treat and defend against the virus.

Trump received a high dose of Regeneron’s (REGN) antibody cocktail, which sparked the company and Eli Lilly (LLY), which is also developing an antibody treatment, to apply for emergency use authorizations (EUA). The U.S. Food and Drug Administration (FDA) has yet to provide an update on these filings from last week, but analysts have anticipated authorizations following Trump’s treatment.

Meanwhile, Operation Warp Speed announced a collaboration with AstraZeneca to test and produce a monoclonal antibody cocktail, which would be provided for free once authorized by the FDA.

Adding to the portfolio of candidates, the National Institutes of Health (NIH) announced Tuesday it

Former CDC director doubles down on importance of masks and social distancing

A top health expert warns US needs a “comprehensive approach” to the Covid-19 pandemic, following a week of several states reporting alarming trends.



a group of people standing on a lush green field: NEW YORK, NEW YORK - SEPTEMBER 26: People with and without masks gather in Sheep Meadow, Central Park as the city continues Phase 4 of re-opening following restrictions imposed to slow the spread of coronavirus on September 26, 2020 in New York City. The fourth phase allows outdoor arts and entertainment, sporting events without fans and media production. (Photo by Alexi Rosenfeld/Getty Images)


© Alexi Rosenfeld/Getty Images
NEW YORK, NEW YORK – SEPTEMBER 26: People with and without masks gather in Sheep Meadow, Central Park as the city continues Phase 4 of re-opening following restrictions imposed to slow the spread of coronavirus on September 26, 2020 in New York City. The fourth phase allows outdoor arts and entertainment, sporting events without fans and media production. (Photo by Alexi Rosenfeld/Getty Images)

“Testing does not replace safety measures including consistent mask use, physical distancing, and hand washing,” Dr. Tom Frieden, the former director of the US Centers for Disease Control and Prevention, said Friday.

His remarks came as a response to the President’s and the first lady’s positive Covid-19 tests. Their diagnoses, Frieden said, serve as “a reminder that Covid-19 is an ongoing threat to our country and can happen to anyone.”

Twenty-four states saw their number of new cases rise at least 10% this week from the week before, according to data from Johns Hopkins University.

The county’s seven-day average of new daily cases — about 42,400 — is more than 20% higher than where it was September 12, when it was at two-month low of about 34,300.

It’s still below a summer peak of roughly 67,000 from July — but health officials have said even daily cases in the 40,000s are far too high if the country wants to avoid a dangerous surge in the coming months, when cold weather will nudge people indoors more often.

Worrying trends across US

In many states, local and state leaders are reporting worrying milestones.

Kentucky on Friday recorded its second-highest number of cases reported in one day, at 999.

And that caps weeks of increases: Its seven-day average of new cases — more than 800 on Friday — is well above the 500s and 600s of early to mid-September, Johns Hopkins data show.

“This week is going to shatter last week’s record for number of cases,” Gov. Andy Beshear said Friday. “The situation is getting very dangerous in Kentucky.”

New York Gov. Andrew Cuomo announced this week the state was facing a “cluster situation” with about 20 zip codes — many of them in New York City — reporting high positivity rates. That comes as thousands of students in New York City returned to schools.

And in Wisconsin, which reported on Wednesday its highest one-day Covid-19 death count — 27 — Gov. Tony Evers this week urged residents not to try and “live like we’re back to the way things used to be.”

Video: 26 states see increases in coronavirus cases (CNN)

26 states see increases in coronavirus cases

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But other US communities pushed further into reopening. Florida cleared the way for bars and restaurants to fully reopen. Mississippi lifted its mask mandate. In California, several counties moved into less restrictive tiers of the state’s reopening plan,

Coronavirus patients in hospital in UK doubles in two weeks

General view of the Chelsea and Westminster Hospital in London as the UK continues in lockdown to help curb the spread of the coronavirus. (PA)
General view of the Chelsea and Westminster Hospital in London as the UK continues in lockdown to help curb the spread of the coronavirus. (PA)

The number of people in hospital with coronavirus has doubled in two weeks as cases continue to rise across the country.

The government said there were 2,276 people in UK hospitals as of October 1, just over double the 1,107 who were receiving treatment on September 17.

There has been a steady increase in hospital admissions throughout September and shows no signs of changing over the first week of October.

There were 6,914 new cases of coronavirus in the UK Thursday, slightly down the past two days where numbers were above 7,000.

During the height of the pandemic in April there were around 19,000 people in hospital with coronavirus in the UK.

Graph patients in hospital with COVID-19 in the UK. (UK Government)
Graph patients in hospital with COVID-19 in the UK. (UK Government)

Read more: Only UK area to come out of local lockdown back on the government’s watchlist

England’s chief medical officer Prof Chris Whitty, said yesterday at a press briefing: “In the North East, North West but also in London, we are seeing a significant uptick in the number of people who are entering intensive care.

“This is not yet at a stage where it is threatening our ability to have intensive care – there is still significant capacity in the NHS system – but this is definitely heading the wrong way.”

Whitty presented a graph at the briefing that showed ICU admissions in London jumped from 0.18 per 100,000 people in the week ending 13 September to 0.42 per 100,000 in the week ending 20 September.

There were similar figures for the Midlands, North West, and the North East and Yorkshire.

Graph showing ICU admissions across England. (UK Government)
Graph showing ICU admissions across England. (UK Government)

Read more: Liverpool, Warrington and parts of North East face tighter coronavirus restrictions

The government has continued to encourage people to follow the guidelines with Boris Johnson insisting as long as people obeyed the rules the country would be able to avoid another full lockdown.

There are signs the government’s new measures are beginning to slow the rate of infection in the UK.

A study found restrictions across the north of England may be pushing down the growth of the coronavirus epidemic, the leader of a large-scale Covid-19.

Professor Paul Elliott, director of the React study – the largest research of its kind in England – said new rules appeared to be taking effect but warned that all age groups were contracting the virus.

Prof Elliott told BBC Radio 4’s Today programme that his study had found a seven-fold increase in the number of people carrying the virus at the age of 65 and over.

Watch: UK coronavirus cases rising – why are deaths still low?

He added: “In the very recent data, and we’re talking about people who did swabs last Saturday, it does seem that the rate of increase of the infection may have slowed a bit.

“So that