Covid-19: An urgent call for global “vaccines-plus” action , 2021, Greenhalgh et al

"An open letter by a group of public health experts, clinicians, scientists

SARS-CoV-2 has infected more than 278 million people globally, with at least 5.4 million deaths recorded by the World Health Organisation as of 26 December 2021. The omicron (B.1.1.529) variant of concern is spreading rapidly.1

Some countries view infection as a net harm and pursue strategies ranging from suppression to elimination.2 They seek to sustain low infection rates through a combination of vaccination, public health measures, and financial support measures (vaccines-plus). Other countries implemented mitigation strategies that aim to prevent health systems from being overwhelmed by building population immunity through a combination of infection and vaccination. These countries rely on a vaccines-only approach and seem willing to tolerate high levels of infection provided their healthcare systems can cope."

...

"For all these reasons, a vaccines-plus approach should be adopted globally. This strategy will slow the emergence of new variants and ensure they exist in a low transmission background where they can be controlled by effective public health measures, while allowing everyone (including those clinically vulnerable) to go about their lives more freely.

We welcome the World Health Organisation’s recent guidance on community and healthcare mask use, but believe more can be done to suppress transmission without adversely impacting economic or social activity."

Open access, https://www.bmj.com/content/376/bmj.o1

 

“I need to be very clear: vaccines alone will not get any country out of this crisis. Countries can and must prevent the spread of Omicron with measures that work today. It’s not vaccines instead of masks, it’s not vaccines instead of distancing, it’s not vaccines instead of ventilation or hand hygiene. Do it all. Do it consistently. Do it well.”

We do have to live differently. It is hard though. Anyone adhering to all of these simultaneously would be treated like they were overly anxious. So adapting and responding to a new and unpleasant reality is considered maladaptive on a social level.

 

I wish that scientists had researched how to reduce the severity of Covid in people of all ages and with underlying health conditions, rather than relying on vaccines alone.

 

I haven't seen any mention of treatments for ordinary people who get sick which can be prescribed by GPs or can be bought from pharmacies. All I see are repeated and repetitive articles about ivermectin and hydroxychloroquine that engender lots of hysteria from lots of sources.

 

There are currently two or three antivirals that are either approved or on the way to being approved. It will be provisional approval I think for most of them. Emergency use only.

Classical development of new drugs can take 10 to 20 years due mostly to clinical trials being necessary. That is why new drugs are not fully approved.

Currently there are also a bunch of drugs used to prevent severity, but only if you are in hospital with severe Covid.

Over the counter stuff is about the same as for a flu or bad cold.

 

I'm not familiar with anything that really helps much with flu or a bad cold other than paracetamol or ibuprofen. I think most products for such conditions are placebo. My husband bought one product intended for my use, offered by a local pharmacy, to treat my dry cough and the active ingredient is glucose plus sugar in various forms.

This is my issue with treatments for Covid - nothing is really available to "ordinary" people, and nothing is really available to shorten the course of the disease. Or if it is, it's experimental or not advertised, and certainly not available over the counter.

The NHS mentions two treatments - but I know quite a few people who've had Covid, a few have had it very badly, (I don't know anyone who has had to go to hospital) and nobody has mentioned being prescribed something that actually helped.

The two things mentioned by the NHS are Sotrovimab (Xevudy) and Molnupiravir (Lagevrio). And I don't know anyone who would have fitted the criteria for them to be prescribed.

 

I believe paxlovid (Pfizer) has been approved in both US and UK, and molnupiravir ( Merk) in UK too.

https://www.nhs.uk/conditions/coronavirus-covid-19/treatments-for-coronavirus/

I think the idea is that they can be used at home but I think we're a way from being ready to do that.

edit Paxlovid's approval. Supposed to be very effective.https://www.gov.uk/government/news/oral-covid-19-antiviral-paxlovid-approved-by-uk-regulator

 

My idea of a good treatment for Covid would be one that could be bought over the counter ready to be used if someone got sick and would shorten the course of the disease if taken right at the start. Such a treatment would reduce the number of people ending up in hospital, would reduce the length of time that people are ill, and would reduce the length of time that people were infectious.

I understand that research on treatment has concentrated on the people who are at great risk because of underlying conditions or because of age, but rather than waiting until people are in hospital and are at death's door seems not to have been a winning formula for reducing deaths and for reducing the burden on hospitals and their staff.

 

I don’t know any details of the trial, if it is a trial, but a couple of people I know in high risk groups for complications from Covid here in the UK were contacted in December requesting if they test positive for Covid to immediately make contact to receive a (new?) drug treatment hopefully prior to any need for hospitalisation aimed at minimising the effects of the virus.

 

From the MHRA on 31st Dec 2021

A COVID-19 treatment called Paxlovid (PF-07321332 and ritonavir) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease.

This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.

Developed by Pfizer, Paxlovid is an antiviral medicine with a combination of active ingredients, PF-07321332 and ritonavir, that works by inhibiting a protease required for virus replication. This prevents it from multiplying, keeping virus levels low and helping the body to overcome the viral infection. Ritonavir slows the breakdown of the second ingredient PF-07321332 in the body, thereby increasing its effectiveness.

The two active substances of Paxlovid come as separate tablets that are packaged together and taken together, twice a day by mouth for 5 days. PF-07321332 is a new antiviral, meaning that it has not been approved for use before. However, ritonavir has been used alongside some HIV medicines for many years to ‘boost’ their activity, which is similar to what it is doing for PF-07321332.

In a clinical trial in high-risk adults with symptomatic COVID-19 infection, a five day treatment course of Paxlovid reduced the risk of COVID-19 related hospitalisation and death within 28 days by 89% when compared to a placebo group when treatment was started within 3 days of the onset of COVID-19 symptoms. The number of hospitalisations and deaths were 0.8% (3 out of 389) in the Paxlovid group compared with 7% (27 out of 385) in the placebo group. Similar favourable results were seen in patients when treatment was started within 5 days of the start of symptoms.

Based on the clinical trial data, Paxlovid is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of the start of symptoms. It has been authorised for use in people aged 18 and above who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.

It is too early to know whether the omicron variant has any impact on Paxlovid’s effectiveness but the MHRA is proactively working with the company to establish this.


Dr June Raine, MHRA Chief Executive, said:
“Today we have given our regulatory approval for Paxlovid, a COVID-19 treatment found to cut COVID-19 related hospitalisations and deaths by 89% when taken within three days of the start of symptoms.

“We now have a further antiviral medicine for the treatment of COVID-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before COVID-19 has progressed to a severe stage.

“I hope the announcement today gives reassurance to those particularly vulnerable to COVID-19, for whom this treatment has been approved. For these individuals, this treatment could be life-saving.”

Sounds a promising treatment if all the steps to get paxlovid to the patient at home can be achieved in 3 days. Let's hope distribution is efficiently organised.

 

Fully approving a new drug might not happen till 2040, 2030 possibly, and something like 2025 if fast tracked. That is how long it takes. They should have started when MERS and SARS were about. Its almost certain these drugs will require a prescription from a doctor.

Clinical trials can last 3 years and additional time for analysis. Early trials, like the ones we have, are shorter in duration, and are done first.

Various forms of provisional approvals, before extensive clinical trials, are here now, and I think Pfizer alone has two such drugs.

How this will work for at home patients under provisional approval is still not figured out I think. I am sure there are lots of issues, and rushing might be a disaster. So would under-resourcing the problem. Does anyone know what the proposed logistics are?

In the meantime Omicron is spreading so fast that almost everyone at risk will be exposed to it in the next couple of months. The USA for example seems to have a spread rate on the order of 15% of the population per month. If you look at many of the new cases graphs they go almost vertical. However this appear to be tailoring off in places like South Africa, where Omicron was first detected, though there are special circumstances in SA that might change how other countries experience Omicron. Death rates also seem to be declining, though I don't think we can be certain yet.

What concerns me most, as I have said before, is how Omicron will impact long term health, and this is extended to all drugs regarding how much they decrease long term negative outcomes. We don't know yet, but we can be cautiously optimistic.

 

I thought that reusing existing treatments that were known about already - their dangers, side effects, and what they actually did in the body - was an idea that a few people came up with. But all that seemed to create was hysteria. I never did find out whether hydroxychloroquine and ivermectin actually had any benefit for people in the early stages of Covid. I did read that one group tried one or both - but they only used them when people were already nearly dead, and it made no difference to outcomes at all.

 

Repurposing existing drugs is much faster because they are already approved. Its been done many times. The problem is that many new antivirals will likely be specific to a limited range of viruses. So repurposing with antivirals only works if its targeting a mechanism in common with both the old and new viruses. I think an earlier post here mentioned one of them.

(Ron Davis is looking at repurposing at least one approved drug for ME, and maybe another three that are not approved but are available for research purposes.)

Repurposing more general purpose drugs like steroids is much more viable than antivirals.

However most of these drugs are dangerous if improperly used. So it is normally necessary to get a medical script at least. Over the counter sales are unlikely except for very innocuous, and usually not very effective, drugs.