The American drug-maker Moderna said Monday it has requested emergency use permission from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine. It has also asked for conditional approval from the European Medicines Agency (EMA).
Moderna’s request comes just 10 days after Pfizer and its German partner BioNTech sought emergency use approval for its vaccine in the United States and across Europe.
In addition, Britain is looking at data from the Oxford-AstraZeneca vaccine trial for a possible emergency approval.
Early data from the Moderna and Pfizer studies show that both vaccine candidates are nearly 95 percent effective against COVID-19. Britain’s Oxford-AstraZeneca group says its vaccine candidate is between 62 to 90 percent effective, depending on how the vaccine is given.
The FDA requires that a vaccine be at least 50 percent effective in order to be considered for emergency use.
None of the three groups has published complete data from their large Phase 3 studies in scientific papers.
In this undated photo from the University of Oxford, a volunteer received a coronavirus vaccine developed by AstraZeneca and Oxford University, in Oxford, England. (University of Oxford/John Cairns)
Question raised about AstraZeneca vaccine
On November 23, the Oxford-AstraZeneca group said its vaccine treatment of a half first dose followed by a full second dose one month later was found to be 90 percent effective. The treatment involving a full dose both times was found to be 62 percent effective.
Scientists, however, remain concerned about the small number of volunteers who received the half first dose.
AstraZeneca told the Reuters news agency that the smaller half dose treatment was at first given to volunteers by mistake. But it said that there should be “no concern.” And, it added that independent scientists and regulators have studied and approved the half dose treatment.
AstraZeneca chief Pascal Soriot said last week that the drug-maker was likely to run more trials to study the effectiveness of its vaccine treatment using the half first dose.
Vials of coronavirus disease (COVID-19) vaccine candidate BNT162b2 are inspected at a Pfizer manufacturing site in Kalamazoo, Michigan, U.S. in an undated photograph. (Pfizer/Handout via REUTERS)
A group of independent scientists known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will now study results from Moderna’s and Pfizer’s Phase 3 trials. The group will advise the FDA on the safety and effectiveness of the vaccine candidates.
On December 10, the FDA will meet to consider Pfizer’s emergency use request. The agency plans to look at Moderna’s request one week later.
If the FDA approves its request, Moderna expects to have 20 million treatments by the end of 2020. Since the treatment requires two shots, that will be enough for 10 million people.
Pfizer says it can supply 50 million vaccine treatments by the end of 2020, enough for 25 million people. It hopes to produce up to 1.3 billion treatments by the end of 2021.
Based on agreements with the U.S. government, vaccines from Moderna and Pfizer will cost between $15 and $25 a treatment. Oxford-AstraZeneca’s vaccine will cost under $4.
Unlike vaccine candidates from Pfizer and Moderna, the vaccine from the Oxford-AstraZeneca group does not require extreme-cold storage. This, along with its lower cost, makes the vaccine a good candidate for many countries around the world. The drug-maker added it will also seek “an Emergency Use Listing from the World Health Organization (WHO)” to make the vaccine available sooner.
General Gustave Perna is chief operations officer for the U.S. Operation Warp Speed program. He said that a COVID-19 vaccine would begin to be sent out within 24 hours of FDA approval.
Men ride on a motorbike past a supply truck of India's Serum Institute, the world's largest maker of vaccines, which is working on a vaccine against the coronavirus disease (COVID-19) in Pune, India, May 18, 2020
Many do not trust vaccines
Johns Hopkins University’s Coronavirus Resource Center reports that nearly 63 million people have now been infected with COVID-19. Nearly 1.5 million have died from the disease.
With several vaccine candidates seeking emergency use approval, the next step is for governments and health officials to prepare for mass vaccinations worldwide. That may not be easy.
Many people do not trust the safety of COVID-19 vaccines, a June 2020 study by Nature Medicine found. The study collected information from more than 13,000 people in 35 countries.
The study asked participants whether they would “accept a vaccine if it were recommended by your employer and was approved safe and effective by the government.” Only 31.9 percent of participants answered “completely agree.”
In the United States, a USA Today/Suffolk survey from August found that two-thirds of Americans said they would not get a COVID-19 vaccine.
Word in This Story
phase - n. a step in the process
dose - n. the amount of medicine that is taken at one time
regulator - n. a government official that controls a public activity by making and enforcing rules
participant - n. a person who is involved in an activity