There are now two promising potential COVID vaccines. This is what we know about them.
Adrianna RodriguezKaren WeintraubUSA TODAY 11/16/20
Nearly seven months after Operation Warp Speed was created, Americans are finally starting to get answers about the candidate vaccines that could potentially slow the coronavirus pandemic.
Operation Warp Speed, the White House-led task force on coronavirus vaccine treatment and development, was created on May 15. Since then, vague and contradicting timelines made by both the Trump administration and leading scientists have muddled predictions about when a COVID-19 vaccine would be available to the public.
However, two big companies leading the race for a vaccine have released promising results from their Phase 3 trials.
Here’s what we know about both trials and what they might mean for the future of the pandemic.
What are the leading COVID-19 candidate vaccines?
Pfizer and the German biotechnology company BioNTechdeveloped one of the candidate vaccines. They announced early findings of their vaccine, BNT162b2, on Nov. 9.https://6926b6316bce5dd601f0850aef7a054e.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.html
Moderna, a Cambridge, Massachusetts-based biotechnology company, released data early Monday on its candidate vaccine, mRNA-1273, which was developed in collaboration with the U.S. government.
Both results are preliminary, with final results expected in as soon as a few weeks.
How effective are the candidate vaccines and what does that mean?
Pfizer released interim results that showed its candidate vaccine was more than 90% effective, after 94 patients developed COVID-19 – the vast majority of whom received the placebo.
Out of Pfizer’s 44,000 volunteers, half the participants received a placebo and half the vaccine, so the new data shows that more people who received the placebo than the vaccine came down with COVID-19.
They were protected a week after the second dose of the vaccine. The two doses are given 21 days apart. Pfizer/BioNTech will do a final check of effectiveness when 164 study participants have fallen ill.
Moderna’s vaccine appears to be 94.5% effective against the disease, after 95 people out of the 30,000 volunteers came down with COVID-19, 90 of whom received the placebo. Eleven people – all in the placebo group – developed “serious” cases of the disease.
A final analysis is expected to include 151 trial volunteers, by which point, statistically, the company can be 90% sure that its findings will hold true.
Are there any side effects to the Moderna, Pfizer vaccines?
Both candidate vaccines reported mild or moderate side effects, mostly pain at the injection site, fatigue and aching muscles and joints for a day or two.
“A sore arm and feeling crummy for a day or two is a lot better than COVID,” said Dr. William Schaffner, professor of health policy and of preventive medicine at the Vanderbilt University School of Medicine.
What makes Pfizer, Moderna candidates different from others?
The Chinese government publicly released the genetic sequence of the virus that causes COVID-19, called SARS-CoV-2, in mid-January, a few weeks after recognizing an outbreak was underway. Scientists focused on the sequence for the so-called “spike protein” found on the surface of the virus, which allows the virus to attach itself to host cells to infect them.
The Moderna and Pfizer vaccines are based on delivering strands of genetic material to turn people’s cells into spike protein factories. The spike proteins created by the body aren’t dangerous because the rest of the virus isn’t present, however, the body now sees the protein and designs immune soldiers to fight it upon future exposure.
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This technology has never been used before in an approved vaccine, and other vaccines have taken 15-20 years to develop and test. The mRNA technology was chosen this time because scientists knew it could be developed quickly. Other COVID-19 vaccine candidates being supported by the U.S. government target the spike protein via a carrier virus or tiny particle.
When can I get a COVID-19 vaccine?
Before the companies can apply to the U.S. Food and Drug Administration for authorization to provide their vaccine to the public, they must clear several more hurdles.
About half the trial participants must be two months past their second shot, to prove that the candidate vaccines are safe. If someone were to develop a severe vaccine reaction, it’s likely to happen within six weeks of receiving it. Pfizer will pass that safety milestone this week. Moderna will take longer because it took longer to enroll trial participants.
The final hurdle concerns production. Both companies will have to show that they can safely produce their vaccine at scale. Pfizer said it will provide the FDA that information before this week, but it’s not clear when Moderna will complete this process.
Finally, the FDA will take some time to review each application, as will an independent committee. While no one knows how long this will take, the regulatory agency is expected to an issue an emergency use authorization for the Pfizer/BioNTech vaccine before the end of the year.
President Donald Trump has promised that vaccine would be distributed within 24 hours of an FDA authorization. It would first go to front-line health care workers.
Moderna said Monday it will have 20 million doses available by the end of this year and another 500 million to 1 billion next calendar year. Pfizer has said it will have as much as 50 million doses of its vaccine manufactured by the end of this year, and another 1.3 billion next year.
While the gears have been oiled up to start cranking out vaccines, scientists have predicted vaccines won’t be available to the general public until summer or fall of 2021.
Follow Adrianna Rodriguez and Karen Weintraub on Twitter: @AdriannaUSAT @kweintraub