Pharmaceutical giant Pfizer reported that final analysis of the Phase 3 trial of its coronavirus vaccine indicated 95% effectiveness in preventing infections.
Pfizer said that final analysis revealed that its coronavirus vaccine does not only have an efficacy of 95% even in adults, but it also caused no serious safety concerns. The new report validates the company's earlier claim of a greater than 90% efficacy.
Final analysis of Phase 3 trial
In the trial, Pfizer discovered 170 cases of coronavirus infection among volunteers, 162 of which were in people who received placebo or plain saline shots while the remaining 8 cases were from participants who received the BNT162b2 vaccine.
In a joint statement, Pfizer and its German partner BioNTech said: "Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%."
The companies continued: "There were 10 severe cases of Covid-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group."
The trial involved an independent group tasked with observing results and side effects. "To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," the firms said.
They added: "The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% following dose 2." In addition, the researchers found that older adults had fewer and milder adverse events.
Pfizer plans to apply for emergency use authorization (EUA) with the US Food and Drug Administration (FDA) "within days" and according to BioNTech CEO Dr. Ugur Sahin, EUA filing will be done by the companies on Friday.
In its news release, the pharma firm said: "These data also will be submitted to other regulatory agencies around the world."
Additionally, Sahin said: "The rapid protection this vaccine provides -- combined with its tolerability profile in all age groups studied so far -- should help make this vaccine an important tool to address the current pandemic."
Updates on Moderna vaccine
Several days ago, Moderna said its vaccine is 94.5% effective based on early data results and that it will apply for approval to use the vaccine.
According to Moderna, it is a "great day," they will seek approval to use the Covid-19 vaccine in the next few weeks. However, this is considered early data and still has key questions that need answers.
The trial, which proved that Moderna vaccine is 94.5% effective, registered 30,000 participants in the U.S. with half being given two doses of the vaccine, four weeks apart. The rest took dummy injections. The analysis was taken from the first 95 to manifest Covid-19 symptoms.
Only five of the coronavirus cases were in people given the vaccine while 90 were in those who received the dummy treatment. The company noted that the vaccine is protecting 94.5% of people.
However, Moderna vaccine production may face logistical challenges, according to Albert Baehny, chairman of Swiss drugmaker Lonza. These logistical challenges may happen when the vaccine has been approved and must be distributed to around 7 billion people.
Lonza, which has partnered with Moderna, announced that it aims to come up with 400 million doses of the vaccine every year. The U.S. company’s target is 500 million to 1 billion doses in total for 2021. People who will take the vaccine will need two doses, as with Pfizer’s shot, manifesting how long it could take, with the present manufacturing capacity, to vaccinate in many countries.
