Pfizer to seek approval from FDA ‘within days’ after analysis finds COVID-19 vaccine 95%
By Erick Johnson
Some 3,000 Blacks participated in Moderna’s clinical trials for the COVID-19 vaccine and several had severe cases of the diseases before taking the vaccine, according to company based in Cambridge, Massachusetts.
The news come as Moderna’s announced that its two-shot vaccine is 94.5% effective against coronavirus based on data after completing phase three of its clinical trials. In the coming weeks, Moderna’s is expected to apply to Food and Drug Administration after it receives more test data later this month.
“These are obviously very exciting results,” said Dr. Anthony Fauci, the nation’s top infectious disease doctor. “It’s just as good as it gets — 94.5% is truly outstanding.”
Early Wednesday, November 18, Pfizer announced its vaccine was 95 percent effective after early data showed its vaccine was more than 90% effective against the disease. Pfizer and its collaborator BioNTech said they will start the Food and Drug Administration approval process “within days” for its candidate vaccine. Pfizer did not disclose the racial identity of its volunteers in the testing phase.
Last month, Moderna’s vaccine trials experienced a slowdown after the company’s private contractors failed to recruit enough Black volunteers. According to Moderna, 30,000 volunteers aged 18 and older participated in the trials. They include volunteers who were high at risk in developing severe complications of COVID-19. Some 7,000 volunteers were over the age of 65. About 5,000 volunteers who are under the age of 65 had high-risk diabetes, severe obesity and cardiac disease that made put them at risk of contracting COVID-19. About 6,000 participants were Hispanic and 3,000 participants were Black.
During the pandemic, COVID-19 has disproportionally affected Blacks and Hispanics more than any other ethnic group. According to Reuters news service, the novel coronavirus has been found to infect Blacks almost three times more than whites, and Blacks are twice as likely to die from COVID-19.
Since the infamous Tuskegee Syphilis Experiment, where hundreds of Black men died of the disease, Blacks have developed a deep distrust of the medical industry. Poverty and lack of access to healthcare have also kept Blacks from seeking medical care.
Moderna’s vaccine is among the furthest developed, with the company getting more than $1 billion in government funding for its product and $1.5 billion for future distribution.
Vaccinations could begin in the second half of December, Fauci said. Vaccinations are expected to begin with high-risk groups and to be available for the rest of the population next spring. Moderna acknowledged that it’s too soon to know how long protection lasts. Still, Moderna is pleased about the progress of its vaccine.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Stéphane Bancel, Chief Executive Officer of Moderna Since early January. We have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease. This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. They are an inspiration to us all.”
In Moderna’s trial, 15,000 study participants were given a placebo, which is a shot of saline that has no effect. Over several months, 90 of them developed Covid-19. They included four Blacks, 12 Hispanics and three Asians. Moderna said 11 volunteers developed severe forms of COVID-19 but did not reveal their racial identity.
Another 15,000 participants were given the vaccine, and only five of them developed Covid-19. None of the five became severely ill.
The company says its vaccine did not have any serious side effects. A small percentage of those who received it experienced symptoms such as body aches and headaches.
More than 11 million COVID-19 cases have struck the U.S. since the outbreak began in March. One million cases were reported last week alone ahead of the Thanksgiving holiday. of them recorded in just the past week – and governors and mayors are ratcheting up restrictions ahead of Thanksgiving. The pandemic has killed more than 1.3 million people worldwide, over 245,000 of them in the U.S.