Pfizer Bets Its Coronavirus Vaccine And Emerging Political Controversy In The US
New York City-based pharmaceutical company, Pfizer Inc. of Pfizer is confident that its COVID-19 vaccine candidate has a huge chance to be proved effective in the clinical trial, as per Reuters that saw the internal documents of the company. A few weeks back, the company shared a view that the effectiveness and safety of the vaccine, which is currently developed together with Germany’s BioNTech SE, would be confirmed by the end of October.
Pfizer already submitted a protocol to the United States (US) Food and Drug Administration (FDA) for the vaccine review and an independent panel of experts known as a Data and Safety Monitoring Board would examine the protocol. Earlier, the company stated that it would soon apply for regulatory approval once the clinical trial is proved to be successful.
Meanwhile, it became a matter of political dispute as the Republican president Donald Trump claimed Wednesday, September 16, 2020, that a vaccine or COVID-19 would be possible before the November presidential election. Former vice-president, who is contesting against Trump, Joe Biden bluntly rejected Trump’s claim and warned that Americans could not trust the president’s words.
Pfizer’s Vaccine Candidate
The first assessment of the company’s trial includes 32 participants, who are infected by the coronavirus, and the trial is under the close observation of the monitoring board. So far, more than 29,000 people have enrolled in the trial that started in July, some receiving the vaccine and the others receiving a placebo.
Reflecting the concerns for vaccine approval, the FDA declared that a coronavirus vaccine must prove to be at least 50 percent more effective than a placebo in a large-scale trial. According to the company’s protocol, Pfizer’s vaccine would need to be at least 76.9% effective to show it works based on 32 infections, which would mean that no more than six of those people who received the vaccine could be infected again.
Pfizer said its interim analyses were designed to show conclusive evidence “as quickly as possible amid the devastating pandemic if our vaccine meets the stringent standards set by FDA.” However, if the drugmaker’s vaccine does not meet the 76.9% efficacy target at this first interim analysis, it would face tougher statistical significance thresholds during subsequent interim assessments.
Political Disputes Over Vaccine
On Wednesday, Trump shared a view that a coronavirus vaccine might be only weeks away and would be possible before the election to be held on November 3, which sparked political controversies in the US. Speaking during a CNN town hall in Moosic, Pennsylvania, Biden remarked, “The idea that there’s going to be a vaccine and everything’s gonna be fine tomorrow – it’s just not rational.”
Several scientists were stunned by Trump’s statement and questioned if it has any sufficient evidence about the vaccine. Earlier, health experts including Robert Redfield, the director of the Centers for Disease Control and Prevention, have stressed that a vaccine for COVID-19 would be less possible until half of the next year.
The US witnessed a death toll of more than 195,000 people while both Biden and Trump will be traveling to Minnesota on Friday, the first day of the early voting, amid the fear of the pandemic. Meanwhile, Trump accused Biden of spreading “anti-vaccine rhetoric,” while Biden emphasized that he would listen to scientists, not the president, regarding a vaccine’s safety.