Ever since the coronavirus pandemic broke out, scientists all over the world have been trying to develop an effective vaccine to tackle the pandemic.
"The National Expert Group on Vaccine Administration for COVID-19 is in talks with all vaccine manufacturers, including domestic and foreign manufacturers."
Coronavirus vaccine: Pharma giant Pfizer and German biotech firm BioNTech’s vaccine for coronavirus is 90% effective, according to the preliminary data that the US-based Pfizer has released. The findings are significant, especially due to the fact the vaccine would be going to the US Food and Drug Administration (FDA) later this month for approval. With these results, its emergency authorisation seems to be a little closer to reality, according to an IE report. Ever since the coronavirus pandemic broke out, scientists all over the world have been trying to develop an effective vaccine to tackle the pandemic, and Pfizer-BioNTech vaccine might be the first one to go through all the three stages of human trials and get approval for use.
Pfizer-BioNTech vaccine: More about it
The vaccine developed by Pfizer and BioNTech makes use of the mRNA technology, the report stated. This means that the cells are instructed on the proteins they need to build by the messenger RNA. So, in the case of this vaccine, the mRNA instructs the cells to recreate the coronavirus’ spike protein.
Therefore, once the mRNA is injected into the body with the use of this vaccine, the cells will follow its directions and imitate the spike protein of the novel coronavirus. This will in turn trigger the immune response of the body, causing antibodies to be developed to fight it.
The mRNA vaccines do not need the cultivation and replication of the virus, as they are synthetically developed, unlike other vaccines. To make such vaccines, scientists just need the code of the part the immune system has to target. The report further stated that one more benefit of such vaccines is that their production can be undertaken at a large scale in bioreactors.
Early results of Pfizer-BioNTech vaccine trials
From the first interim efficacy analysis, it has been found that the vaccine is effective in fighting off the COVID-19 infection. The report stated that the vaccine proved to be over 90% effective in prevention of COVID-19 among those participants who were administered a second dose of the vaccine as compared to the volunteers who only got placebo. Pfizer also said that based on the data from the late-stage trial, they have not found any serious concerns regarding safety.
Several health regulators and organisations, including the US FDA, have indicated that a vaccine for coronavirus must show the ability to protect a minimum of 50% of the recipients. Based on this threshold, the Pfizer and BioNTech vaccine seems promising based on the findings.
Pfizer CEO Albert Bourla said in a statement that the findings mean that they are a step closer to potentially being able to provide a breakthrough in the fight against the pandemic. Bourla added that this was the first step, but a critical one, in the development of a safe and effective vaccine.
The vaccine’s third phase of trials had begun on July 27. So far, the study has enrolled 43,538 participants, and of these, 38,955 have received a second dose of the vaccine by November 8.
What does this mean for Pfizer’s emergency approval from the US FDA?
While the findings are significant, they don’t guarantee that the candidate would receive the emergency approval from the US drug regulator. The results had only been based on the data from 94 out of the 40,000 participants who have been administered the vaccine. Bourla said that the company cannot apply for Emergency Use Authorisation of FDA based on these results itself, and they would need more data on safety as well. The Pfizer CEO added that the company is working on collecting more data as part of the study.
BioNTech and Pfizer have estimated that they would need time till November thor week to get two months of safety data after the second and final vaccine dose.
Pfizer vaccine: What does this mean for India?
The positive results from the vaccine are very encouraging. However, as conditions stand now, India would not get access to this vaccine, the report stated. As of now, Pfizer-BioNTech have signed deals involving hundreds of millions of vaccine doses with the US, Japan, the UK and the EU region.
According to the current projections, up to 50 million doses of the vaccine would be produced globally in 2020. This would go up to 1.3 billion doses in the next year.
The Centre had been in an ‘initial meeting’ with Pfizer’s Indian subsidiary back in August, but there has been no progress since then in this regard.
Whether the vaccine would be launched in India or not would be dependent on the firms approaching the Central Drugs Standard Control Organisation, which is the drug regulator in the country, and seeking approval for conducting human trials here. As per the requirements in India, a vaccine would only be allowed to launch in the country once local trials have been conducted.
At present, India has been focusing on five major vaccine candidates, which are being tested by the Serum Institute of India, Dr Reddy’s Laboratories, Biological E, Bharat Biotech, and Zydus Cadila.
Roadblocks in scaling up of Pfizer-BioNTech COVID-19 vaccine
The report stated that the vaccine could have logistical issues with regard to cold storage, as it needs to be store at below -90°F. This means, an ultra-cold storage system would be needed because if the vaccine is stored at refrigerated temperatures for over two days, it could become ineffective.
This is especially a major issue for countries like India, which is still working on its cold storage facilities to store vaccines at the refrigerated temperatures. Even countries having a robust cold storage system in place could have to increase investment to be able to meet such conditions.