Milestone COVID-19 vaccine offers 90% protection
A coronavirus vaccine unveiled by pharmaceutical companies Pfizer and BioNTech can potentially prevent more than 90% of people from getting COVID-19, it has been announced.
According to the companies, the vaccine has been tested on 43,500 people in six countries and has led to no safety concerns so far.
In a statement released yesterday, Monday, November 9, Albert Bourla, chairman of Pfizer, said: “The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it. This means we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic. This is a first but critical step in our work to deliver a safe and effective vaccine.”
These results have exceeded the US Food and Drug Administration’s criteria for approving a COVID-19 vaccine, which demands an efficacy of at least 50% in placebo-controlled trials.
Pfizer and BioNTech told the BBC that 50 million doses of the vaccine — which would be the first vaccine to use mRNA technology — could be manufactured this year, and a further 1.3 billion doses produced in 2021.
The vaccine works by injecting part of the virus's genetic code in order to train the immune system to make both antibodies and T-cells to fight the coronavirus.
Bourla noted, however, that the company could not apply “for FDA Emergency Use Authorization based on these efficacy results” alone. “More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study,” he said. The company added that it planned to apply for emergency approval to use the vaccine by the end of the month.
However, the breakthrough has given rise to many questions for IP practitioners, along with governments and companies who wish to have access to the vaccine. Unlike Moderna, Pfizer and BioNTech have not committed to waiving the enforcement of their vaccine-related patents during the pandemic.
Furthermore, the two companies face a lawsuit from biotechnology company Allele Biotechnology which alleged in October that the vaccine was developed using Allele’s mNeonGreen fluorescent protein without the company’s permission.
Until the vaccine has been approved it will not be possible for countries to begin their vaccination campaigns. According to the two companies, they will be able to supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. Each person requires two doses for the vaccine to be effective.
The UK government has confirmed that the UK should get 10 million doses by the end of the year, with a further 30 million doses already ordered.
While there are around a dozen vaccines in the stages of phase 3 trials, this is the first candidate to show positive results. Former vaccine frontrunner Moderna is not expected to have the trial data required to go for approval until November 25, while AstraZeneca’s partnership with the University of Oxford is expected to reveal results by the end of this year, according to a report in the Financial Times.
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