According to Pfizer CEO Albert Bourla, the company’s study will show if there is a “good chance if the product works” by October-end, distribution would depend on license issuances from regulators such as the FDA
Pfizer and BioNTech’s COVID-19 vaccine candidate, if proven to be safe and effective by federal regulators, could reach Americans before 2020-end, according to Pfizer CEO Albert Bourla.
"I cannot say what the United States Food and Drugs Administration (FDA) will do, but I think is a likely scenario and we are preparing for it," Bourla said during American channel CBS’ “Face the Nation” segment.
He said they “will be ready” in case of good indicators from the vaccine study, FDA and advisory committee and have already “started manufacturing and have already manufactured hundreds of thousands of doses” in preparation, Fox Business reported.
According to Bourla, Pfizer’s study will show if there is a “good chance if the product works” by October-end, the distribution would depend on license issuances from regulators such as the FDA.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The vaccine candidate is moving towards Phase 3 trial with 30,000 participant enrolment targeted by next week. Overall Pfizer is aiming for close to 44,000 participants, so as to increase diversity and include more vulnerable populations, adolescents as young as 16 and individuals with chronic conditions such as HIV, Hepatitis C or B, it added.
“I think we should strive to have as more a diverse population as possible, but right now we are not bad. We try of course to increase it, particularly an emphasis on African-Americans and Latinos.” Bourla added.
Follow our LIVE Updates on the coronavirus pandemic here
Pointing out that Pfizer turned down inclusion in the US government’s $10 billion Operation Warp Speed initiative for accelerated COVID-19 vaccine development, Bourla said this was done in an effort to "liberate our scientists from any bureaucracy” as “money from someone always comes with strings” and would entail providing detailed and continuous progress reports.
“I didn't want to have any of that. I gave them an open chequebook so that they can worry only about scientific challenges, nothing else. I also wanted to keep Pfizer out of politics, by the way,” he said.
Acknowledging that the candidate could fail, Bourla argued that any potential financial hit – despite the $1.5 billion investment, would not break the company.
The US has signed a $1.95 billion agreement with Pfizer and BioNTech for at least 100 million doses of its coronavirus vaccine after it is approved by the FDA, with room for acquisition of another 500 million doses.
Follow our full COVID-19 coverage herehttps://www.moneycontrol.com/news/tags/coronavirus.html