The EU’s drug watchdog on November 19 backed Merck’s anti-COVID pill for emergency use ahead of its formal authorization and started reviewing Pfizer’s antiviral treatment as cases soar across Europe.
The two pills by the US pharma giants represent a potentially groundbreaking step in the fight against coronavirus as studies show they cut the risk of hospitalization and death in high-risk patients.
The European Medicines Agency (EMA) said that while the Merck pill was not yet approved, it had “issued advice” so that individual countries in the 27-nation EU could decide whether to use it in case of a surge in infections.
The EU’s drug regulator on Dec 16 allowed member states to use Pfizer’s new COVID pill ahead of its formal approval, as an emergency measure to curb an Omicron-fuelled wave.
Pills like those by US pharma giant Pfizer and rival Merck have been hailed as groundbreaking because they do not need to be injected or taken intravenously, making them more accessible.
Pfizer said this week that its Paxlovid pill reduced hospitalisations and deaths in vulnerable people by almost 90 percent.
“The medicine, which is not yet authorised in the EU, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease,” the EMA said in a statement.
“EMA issued this advice to support national authorities who may decide on possible early use of the medicine… for example in emergency use settings, in the light of rising rates of infection and deaths due to COVID-19 across the EU.”
Merck’s pill decreases the ability of the coronavirus to multiply by increasing the number of mutations in its genetic material (or RNA).
The Pfizer pill uses a different method, belonging to a class of antivirals called “protease inhibitors”, which block the action of an enzyme that is critical to viral replication.
It is a combination of a new molecule, PF-07321332, and HIV antiviral ritonavir.
Europe has been searching for whatever methods it can to curb a fourth wave of COVID cases that has already prompted several countries to tighten restrictions.
Why not approve Ivermectin?
When a new epidemic breaks out, one for which there is no approved medication available that will cure the patient it has always been the aim of the medical community to see if there are any approved drugs that can be repurposed to cure the patient, because it takes too long to develop brand new drugs.
When the COVID-19 pandemic broke out there was a wild scramble to see what other drugs were available, most of it in other countries. One such effort, in Marseille, France, by a Muslim doctor caught the attention of then President Trump, and he started promoting it. It involved Hydrochloroquine, Zinc and Azithromycine, and it worked remarkably well when taken early, people were cured in 5 days, but it had one fatal flaw, the main drug is generic, and therefore the medical-industrial complex could not make any money on it, so no studies in the U.S.A could be performed by it and so, it could not be approved. Plus, it had been promoted by Trump, and he was no medical expert. Many countries with limited medical budgets called on its wide use as an early treatment with good results, the death rate of these, mostly developing countries was substantially lower than the advanced countries. Here is some early evidence.
The sub-Saharan countries that are plagued by river blindness had almost no COVID cases early during the pandemic, but no- one noticed. It turns out that in those countries they are using Ivermectin to prevent river blindness. This also blocks COVID-19, and so, Ivermectin was inadvertently repurposed. How successful is it? The data is here. India and Indonesia have drastically reduced their COVID-19 cases by the use of Ivermectin, results here. Japan reducrd their COVID-cases by 99%, see here.
How well does Ivermectin fare compared to vaccination? Let’s check 3 nations, all tropical: Covid-19, Ivermectin compared to Vaccination. 3 nations: Haiti, Dominican Republic and Singapore.
. it works the same way as IverThe results speaks for themselves, that is for everybody except NIH, CDC and FDA. To protect their investment in COVID-19 disease management Pfizer is coming out with a pill, PF-07321332 which has been dubbed Pfizermectin by the social media, and for good reason, it works the same way as Ivermectin, but the molecule used is quite different. It is more specifically targeted at COVID-19, delta variant, and as such is even more efficient than Ivermectin, but Ivermectin is more broadband, and may work well against all future mutations of the virus and even against the next pandemic in the COVID family. The great advantage of the Pfizer pill is that it is expensive and as such will be approved lickety-split,, whereas the true cost in Africa for the Ivermectin pill is 6 cents.
Anyhow, here is Dr, John Campbell with the best presentation of how Ivermectin works I have seen. It has many scientific references.
Len Bilén's blog, a blog about faith, politics and the environment. 