With agency report
With the second wave of the outbreak of Covid-19, the recent annoynced found cure by Pfizer/BioNTech is indeed a medicine to the heart.
With many countries comtemplating a fresh lockdown to prevent further escalation of the spread of the virus, the nothing can be more gladdening than the news of the role out of the Pfizer/BioNTech vaccine which is expected to be applied from Monday.
The Pfizer/BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process.
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.
“The vaccine contains a small piece of the [Covid-19] virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein,” the FDA said.
When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against [Covid-19].”
The vaccine is given as two injections, 21 days apart, with the second dose being a booster. Immunity begins to kick in after the first dose but reaches its full effect seven days after the second dose.
The vaccine must be stored at ultra-low temperatures, which makes distribution difficult. Special shipping containers that use dry ice will be used to transport frozen vials direct to the point of vaccination, Pfizer says.
The pharmaceutical company has agreed a deal to supply the US with 100 million doses of the vaccine by March.
An additional 200 million doses of a second vaccine, developed by Moderna and the National Institutes of Health, will be provided by June. However this vaccine is still seeking approval in the US.
The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin.
Pfizer/BioNTech say they also have the necessary safety data that regulatory bodies require, and will submit the vaccine for emergency approval within days to the US Food and Drug Administration and other regulators around the world.
The Pfizer vaccine, which uses innovative mRNA technology, was the first to publish an early analysis from its phase 3 trials involving 43,000 people worldwide. That analysis of 94 cases of Covid illness showed more than 90% efficacy and caused celebration around the world as it appeared clear that a vaccine was at least possible against the coronavirus that has wreaked havoc in people’s lives and countries’ economies.
The final results have been published just a week later, based on 170 people in the trial who fell ill with the disease. The new data is even better, with 95% efficacy – which means that the vast majority of those who developed symptoms and were confirmed as Covid cases had not been given the Pfizer experimental vaccine. Only eight had been given the vaccine, while the other 162 were in the placebo group.
In further excellent news, a good immune response was “consistent across age, gender, race and ethnicity demographics” and the jab had over 94% efficacy in those aged over 65, Pfizer said. That is remarkable, because many vaccines do not work so well in older people, whose immune systems weaken with age.
Of those taking part in the trial, 42% were from diverse ethnic backgrounds and 41% were aged between 56 and 85, which is also important as people from BAME groups have been disproportionately affected by the virus.
Ten of the cases resulted in severe illness, as opposed to mild symptoms, and only one of those had been given the experimental vaccine. No serious side-effect issues have been reported, although 2% of people said they suffered a headache and fatigue.
Pfizer/BioNTech confirmed they would go within days to regulators around the world for emergency authorisation based on their final data and also manufacturing quality data. They have undertaken to deliver 50m doses of the vaccine this year, with up to 1.3bn next year. The UK has pre-ordered 40m doses and is likely to get a small amount this year. Europe has ordered 200m while the US has ordered 100mn.