Comparison Between Vaccine and Placebo Groups
Supervised by Scientists Unrelated to Pfizer
[Asia Economy Reporter Kwon Jae-hee] Interest is gathering on the future release schedule as interim clinical trial results show that the vaccine jointly developed by the U.S. pharmaceutical company Pfizer and the German company BioNTech has a prevention efficacy of over 90% against the novel coronavirus infection (COVID-19).
According to Pfizer and AP News on the 9th (local time), the Phase 3 clinical trial of Pfizer and BioNTech's COVID-19 vaccine candidate 'BNT162b2' began on July 27.
The total number of trial participants was 43,538, and Pfizer explained that about 42% of the global participants and about 30% of the U.S. participants "had diverse racial and ethnic backgrounds."
The trial method involved dividing participants into two groups, with one group receiving the vaccine candidate and the other receiving a placebo.
The trial was conducted in a double-blind manner, meaning neither the participants, the doctors, nor Pfizer knew who received which treatment.
The authority to verify who received the vaccine candidate and who received the placebo was held exclusively by an independent organization called the 'Data Safety Monitoring Board (DSMB),' composed of scientists and statisticians unrelated to Pfizer, who supervised the entire trial process.
The vaccinations were administered twice, with the second dose given three weeks after the first.
Additionally, follow-up observation began one week after the second dose to check whether any participants tested positive for COVID-19 or showed symptoms.
Pfizer announced that as of the 8th, 38,955 participants, accounting for 89.5% of the total, had completed the second dose.
The interim results announced that day analyzed 94 participants who were infected with COVID-19.
Initially, Pfizer planned to start analyzing vaccine efficacy when 32 participants were confirmed COVID-19 positive, but this number was criticized as too small, and later an agreement was reached with the Food and Drug Administration (FDA) to analyze at 62 cases.
However, while Pfizer and the FDA were negotiating, the number of confirmed cases among participants increased to 94, and these were ultimately analyzed.
President Donald Trump expressed dissatisfaction on Twitter that the FDA and the Democratic Party did not want him to have a vaccine before the election, implying that Pfizer's interim results announcement was delayed.
In response, media outlets such as The Washington Post (WP) and The New York Times (NYT) reported that the DSMB was only able to review the data on the 8th because Pfizer and the FDA were negotiating the number of cases to analyze.
Pfizer did not disclose the exact number of infected participants who received the vaccine candidate versus the placebo. Instead, it only explained that less than 10% of the 94 confirmed cases had received the vaccine candidate.
Pfizer's clinical trial will continue until 164 participants are confirmed COVID-19 positive.
On the same day, Pfizer stated that no serious safety concerns had been observed so far and that it plans to apply for emergency use authorization from the FDA in the third week of this month.
However, AP News reported that the FDA's condition of "tracking and observing more than half of the trial participants who completed the second dose for two months before applying for emergency use authorization" means this will likely be achieved by the end of this month.
Pfizer announced that the maximum expected production volume of the COVID-19 vaccine is 50 million doses (one dose equals one injection) this year and 1.3 billion doses next year under the current circumstances.
AP News predicted, "Pharmaceutical companies are already stockpiling inventory in preparation for vaccine approval, but the first vaccine will be in short supply and distribution will be prioritized."
Other pharmaceutical companies developing COVID-19 vaccines, such as Moderna, are expected to apply for approval as early as the end of this month, and the British company AstraZeneca recently stated that it hopes to prove the vaccine's efficacy by the end of the year.
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