Day: 16 July 2021

U.S. Medicines Regulator Will Decide Whether to Fully Approve the Pfizer Covid Vaccine by January 2022

The Food and Drug Administration (FDA) will decide on whether to fully approve the use of the Pfizer Covid vaccine in the U.S. for those aged 16 and over no later than January 2022, it has been announced. The vaccine is currently only authorised for emergency use in Americans aged 12 and over and has been given to millions of people across the world. The MailOnline has the story.

According to a press release from the [Pfizer and BioNTech] on Friday, the federal health agency’s goal date for a decision is by January 2022.

If approved, the vaccine will be the first fully approved Covid shot and could help ease vaccine hesitancy among some Americans due to the longer-term data required for full FDA approval. 

As of Friday, more than 186.5 million shots of the vaccine have been administered in the U.S., according to data from the Centers for Disease Control and Prevention (CDC). 

Because Pfizer’s vaccine is currently approved for use on an emergency basis, it is still considered somewhat experimental despite data showing it is safe and effective.

Additionally, emergency use authorisation requires less clinical trial data, with the FDA only requiring two months of follow-up before approving the shot for those 16 and older in December 2020.

The designation is also intended to be temporary.

If and when the shot is fully approved, companies and schools may feel more comfortable requiring employees and students to get it. 

The decision would also allow the vaccine makers to market their shots directly to the general public.

According to the press release, Pfizer and BioNTech completed the rolling submission of data to the FDA in May 2021.

It includes data from the Phase III trial completed last year and six months of follow-up data rather than two months.

Although the shot is currently approved for use in teenagers and adults, the full approval would only be for those aged 16 and older because emergency authorization for Americans aged 12 to 15 only occurred in May.

The companies plan to apply for full approval in teens as well, but only after six months of follow-up data is available, the press release states. …

Moderna Inc has also filed for full approval from FDA for its Covid vaccine, announcing the news on June 1st. …

The decision to fully approve Moderna’s vaccine will likely come after the Pfizer decision due to Moderna submitting its application later.   

Worth reading in full.

Government Not Planning to Change Sensitivity of NHS Covid App

Reports that the Government could lower the sensitivity of the NHS Covid app in weeks – after half a million English people were ‘pinged’ in just seven days – have been denied, with officials only going so far as to say that the system will be kept under “constant review”. Sky News has the story.

Ministers had indicated that the contact tracing tool would be tweaked, with Transport Secretary Grant Shapps telling Sky News last Friday, July 9th, it would be “tailored” to keep it aligned with new social distancing rules.

However, Sky News understands there are no current plans to change the “sensitivity of the risk threshold” – but the app will be kept under “constant review”.

Business groups have expressed frustration at the increasing number of workers being pinged by the app and told to stay at home. …

The Prime Minister has previously said he understands people’s frustrations with the app, but his spokesman said on Friday that it was “working as it is designed to do”.

But it will be kept “under review”, they added.

The spokesman also dismissed reports in the Telegraph of the app pinging people through brick walls, saying it used “low energy Bluetooth”, thus making that situation “highly unlikely”. …

Government sources have sounded increasingly downbeat on the so-called “test to release” plan… with the results from pilots into strategy only due to report in the next two months.

The decision not to tweak the app for the time being comes after Labour leader Sir Keir Starmer equated it to “taking the batteries out of the smoke alarm”.

Worth reading in full.

Up to 1.6 Million People in England Told to Self-Isolate in a Single Week

Up to 1.6 million people in England were told to self-isolate in a single week, according to the Guardian, which has taken into account the 500,000 people ‘pinged’ by the NHS Covid app in the week up to July 7th, as well as those told to isolate by Test and Trace and the children told to stay at home because others in their ‘bubble’ tested positive for Covid. Yet despite the major disruption this is causing to education, businesses and the nation’s mental and physical health, the NHS Covid app won’t be changed for “weeks” (never mind school bubbles).

A week ago, after forecasts that up to 10 million would be forced to isolate within a six-week period, Jenny Harries, Head of the new Health Security Agency, told MPs the Government planned to tweak the Covid app to make it less sensitive and account for the majority of adults now being vaccinated. The need to isolate after exposure to a confirmed Covid case will be dropped for fully vaccinated people in England from August 16th.

On Thursday, however, Communities Secretary Robert Jenrick said while the Government accepted the technology needed tweaking, “we’re going to give further thought to how it is a proportionate response”, adding: “The Government is going to be setting out its plans in the coming weeks, so I’m not going to pre-empt those.

“It is important we have the app, that we take it seriously and that when we do get those messages, we act accordingly,” he told the BBC.

Data published by the Government and analysed by the Guardian found the number of people being urged to quarantine is rising sharply.

About 337,695 people were told to isolate by NHS Test and Trace for being identified as a close contact of someone who had tested positive in the week of July 1st-7th, according to the latest statistics.

Over the same period, 520,194 people were also pinged by the Covid app. The number of schoolchildren forced into isolation because others in their “bubble” were positive Covid cases stood at 624,000 in the week of July 2nd-8th.

With the addition of those who themselves tested positive, totalling 194,005, that meant there were up to 1,675,894 people told to isolate over a one-week period in England. There may be a degree of crossover between the groups, with some individuals potentially being counted more than once.

The figure for the previous week stood at 1,206,612 – suggesting the number of people being urged to stay at home is climbing and could continue to do so after the dropping of nearly all Covid restrictions in England from Monday.

Worth reading in full.

Stop Press: According to MailOnline, up to six million people a week could be told to stay at home by the end of July.

Brits Will “Of Course” Face New Lockdown If Covid Situation Becomes “Unacceptable”, Government Minister Confirms

We haven’t yet reached lockdown’s “terminus date“, but Government officials are already signalling that restrictions could be reintroduced in weeks if the Covid situation becomes “unacceptable”.

Chief Medical Officer Chris Whitty said on Thursday that a “scary” growth in hospitalisations could leave the NHS “in trouble again surprisingly fast“, meaning that in “five, six, seven eight weeks’ time”, the Prime Minister may need to “look again” at reintroducing restrictions.

A Government minister has this morning echoed Whitty’s warning, telling Sky News that: “Of course, if we get into a situation where it’s unacceptable and we do need to put back further restrictions, then that, of course, is something the Government will look at.” The MailOnline has more.

Solicitor General Lucy Frazer suggested it was the right time to open up because of the vaccination drive – which has reached 90% of Britons.

But with cases continuing to soar, hospital admissions tracking above some of SAGE’s worst-case projections, and deaths having hit a four-month high, she warned that Number 10 may be left with no choice but to consider reimposing tough restrictions. …

England’s Chief Medical Officer last night cautioned the U.K. could still “get into trouble again surprisingly fast” and hospitals may face “scary numbers” within a matter of weeks. 

Making it clear the country was not on an irreversible path to freedom despite Number 10 pushing ahead with step four of the ‘roadmap’ to normality on Monday, Professor Chris Whitty said: “We are not by any means out of the woods yet.” …

The Prime Minister [has] sounded a cautious note… and called on people not to “go wild” and immediately rush to take advantage of the final easing – which includes lifting work-at-home orders and reopening nightclubs. …

Saying restrictions should be eased on July 19th, Ms Frazer told Sky News: “I think the Health Secretary has been very clear, as has the Prime Minister, that we will see infections rise. …

“It is really important that we get the balance right between ensuring that we keep this virus under control and we take the necessary clinical measures to do that, but that we also recognise that there are consequences of not opening up and not allowing people to go about their daily lives.”

Worth reading in full.

News Round-Up

Infections are Peaking Nationwide as They Fall in the Unvaccinated, Says Professor Tim Spector

Reported positive Covid tests hit a new recent high yesterday of 48,553, confirming for many that their fears of a big exit wave are coming to pass.

However, Tim Spector, lead scientist on the ZOE Covid Study app and Professor of Genetic Epidemiology at King’s College London, had another message: according to his data, infections are already peaking.

ZOE data for July 11th (data from the app is always four days behind) showed 32,920 symptomatic infections in the U.K., and this appears to have peaked (R is currently estimated to be around 1) and may already be starting to drop (see above).

Why is this so different to the new daily ‘cases’ reported by the Government, which show no obvious sign of peaking?