ROCHESTER, N.Y. (WROC) The race continues to develop a COVID-19 vaccine. Several vaccines are in various stages of research and some are starting to break away from the pack, according to Daniel Culver, DO, of Cleveland Clinic.
There are a number of vaccines currently in advanced stage clinical trials, what we call stage three clinical trials, which are really the last stage before application for approval to the FDA, he said.
There are four vaccines, in particular, making their way toward the finish line for approval, hopefully, in the weeks ahead.
Two of those are RNA based vaccines, using a novel strategy thats new to vaccine development.
Two others are using a viral vector, where a cold virus acts as a type of Trojan Horse to attack infection.
Dr. Culver says if one of the vaccines receives emergency use authorization from the FDA, we may hear about an approval in December.
High risk populations, like first responders and healthcare workers, are likely to receive the vaccine first.
If all goes well, the general population may have access in the second or third quarter of 2021.
We probably will want to proceed with multiple vaccines. We still dont know the durability of the vaccines, said Dr. Culver. We still dont know how these will work in relatively uncommon populations, immunocompromised populations, the elderly, and so I dont think we can bank on any one of these, even if its the first one and most effective, to be the one that will ultimately be the best for people.
Dr. Culver reminds us the vaccine information weve heard in the news is still preliminary and should be taken with a grain of salt.
He said its still too early to know whether any of the vaccines being studied will be effective and durable against coronavirus.
For me its really cool to be something thats really historic in nature. The other thing I would say is, as the Dean of Students at Tulane, this has been a rough semester. And you see that there are life and death consequences of COVID-19, but this is really impacting all of us everyday, said Woodley.
In this March 16, 2020, file photo, Neal Browning receives a shot in the first-stage safety study of a potential vaccine for COVID-19 at the Kaiser Permanente Washington Health Research Institute in Seattle. Moderna Inc., said Monday, Nov. 16, its COVID-19 vaccine is proving to be highly effective in a major trial.
This story is part of Houston Public Medias ongoing coronavirus coverage. Click here to see more of our coronavirus news and resources.
Public health officials are optimistic about the chances of a COVID-19 vaccine likely to be distributed in limited supply by the end of this year but medical experts are also cautioning people not to let their guard down, especially as the holiday season rapidly approaches.
Pfizer said it expects to release a COVID-19 vaccine that's 90% effective by the end of November, pending federal approval. Once that happens, state officials will be in charge of distribution. Biotech company Moderna Inc., meanwhile, said its vaccine looks to be 95% effective, and also hopes to ship by the end of 2020.
But dont count on getting it right away. When the vaccine does eventually arrive in Harris County, health care workers, first responders, and those most at risk for COVID-19 will get the initial doses, said Harris County Public Health Director Dr. Umair Shah.
"You're not gonna have enough vaccine initially to be able to cover the entire population," Shah told Houston Public Media. "Those are the areas of prioritization, but we want to be encouraging about getting the vaccine out to our community members as quickly as possible."
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With cases and hospitalizations again on the rise in Greater Houston going into the holiday season, Shah and other health officials say the news should motivate the community to take mask wearing and social distancing seriously, even while remaining hopeful for the future.
"This is what we all want to see," Shah said. "I would think it's gonna be December or likely in the first part of 2021, when you're really gonna start to see it in local communities like Harris County and in Houston."
No timetable has been given for when a vaccine will be available to Harris County's general population. But the anticipated quick release to first responders had some healthcare workers worried early on.
"I was concerned that we were rushing these vaccines through," said Serena Bumpus, director of practice with the Texas Nurses Association.
But, she added, "to see a 90% efficacy rate for the vaccine, particularly the Pfizer vaccine, that tells me they are taking this seriously and they're looking at this cautiously to ensure that potential side effects could be minimized."
Still, some nurses across the state remain hesitant to take the initial dose, Bumpus said. That's because they're treating COVID-19 patients right now, who are showing confusing initial symptoms.
"Every day we learn something new," she said. "There are some people who are experiencing this virus who've never even had a fever before. It just feels like seasonal allergies, and so it's new developments like that, we're still trying to figure out."
Harris County hospitals collectively reported more than 200 COVID-19 patients in their ICU beds for five out of seven days last week, the highest number since Sept. 12.
The COVID-19 positivity rate at testing sites in Greater Houston is back on the rise, with the Texas Medical Center reporting a reproduction rate above 1.0 for the virus, indicating an increase in spread.
Now, the public health message leading into Thanksgiving is the same as it was just before the summer surge: Wear a mask, socially distance, and wash your hands. Alongside testing and contact tracing, those remain the best defenses against further spread in Harris County, until a vaccine arrives.
"We have something that's going to really be effective, and allow us to see the path forward," Shah said. "Now what we need to do is make sure that the safety data matches the effectiveness data. If you have both, now we've got something, and that's what's encouraging to all of us in public health."
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Moderna said Monday its COVID-19 vaccine is proving to be highly effective in a major trial, a second dash of hope in the global race for a shot to tame a resurgent virus that is now killing more than 8,000 people a day worldwide.
The company said its vaccine appears to be 94.5% effective, according to preliminary data from Modernas ongoing study. A week ago, competitor Pfizer Inc. announced its own COVID-19 vaccine appeared similarly effective news that puts both companies on track to seek permission within weeks for emergency use in the U.S.
The results are truly striking, said Dr. Anthony Fauci, the U.S. governments top infectious diseases expert. Earlier this year, Fauci said he would be happy with a COVID-19 vaccine that was 60% effective.
A vaccine cant come fast enough, as virus cases topped 11 million in the U.S. over the weekend 1 million 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.
Dr. Stephen Hoge, Modernas president, welcomed the really important milestone but said having similar results from two different companies is whats most reassuring.
That should give us all hope that actually a vaccine is going to be able to stop this pandemic and hopefully get us back to our lives, Hoge told The Associated Press. He added: It wont be Moderna alone that solves this problem. Its going to require many vaccines to meet the global demand.
The National Institutes of Health helped create the vaccine Moderna is manufacturing, and NIHs director, Dr. Francis Collins, said the exciting news from two companies gives us a lot of confidence that were on the path towards having effective vaccines.
But were also at this really dark time, he warned, saying people cant let down their guard during the months it will take for doses of any vaccines cleared by the Food and Drug Administration to start reaching a large share of the population.
If the FDA allows emergency use of Modernas or Pfizers candidate, there will be limited, rationed supplies before the end of the year.
Both vaccines require people to get two shots, several weeks apart. U.S. officials said they hope to have about 20 million Moderna doses and another 20 million doses of the vaccine made by Pfizer and its German partner BioNTech to use in late December.
Exactly who is first in line is yet to be decided. But Health and Human Services Secretary Alex Azar said the hope is that enough doses are available by the end of January to vaccinate adults over 65, who are at the highest risk from the coronavirus, and health care workers. Fauci said it may take until spring or summer for enough for anyone who is not high risk and wants a shot to get one.
Another important message: Additional vaccines that work in different ways are still in testing and despite the promising news about Modernas and Pfizers shots, more volunteers are needed for those studies.
Stocks opened higher on the news on Wall Street. Moderna was likely to hit an all-time high. Markets in Asia and Europe were up sharply as well.
Modernas vaccine is being studied in 30,000 volunteers who received either the real thing or a dummy shot. On Sunday, an independent monitoring board examined 95 infections that were recorded after volunteers' second dose, and they discovered all but five illnesses occurred in participants who got the placebo.
The study is continuing, and Moderna acknowledged the protection rate might change as more COVID-19 infections are detected. Also, its too soon to know how long protection lasts. Both cautions apply to Pfizers vaccine as well.
But Modernas independent monitors reported some additional, promising tidbits: All 11 severe COVID-19 cases were among placebo recipients, and there were no significant safety concerns. The main side effects were fatigue, muscle aches and injection-site pain after the second dose.
The Cambridge, Massachusetts, companys vaccine is among 11 candidates in late-stage testing around the world, four of them in huge studies in the U.S.
Both Modernas shots and the Pfizer-BioNTech candidate are so-called mRNA vaccines, a brand-new technology. They arent made with the coronavirus itself, meaning theres no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
Another steep challenge: distributing doses that must be kept very cold. Both the Moderna and Pfizer shots are frozen but at different temperatures. Moderna said that once thawed, its doses can last longer in a refrigerator than initially thought, up to 30 days. Pfizers shots require long-term storage at ultra-cold temperatures.
Pfizer CEO Albert Bourla tweeted that that he was thrilled at Modernas news, saying, Our companies share a common goal defeating this dreaded disease.
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The first doses of a COVID-19 vaccine are expected to reach the Coastal Bend at least by January if not sooner.
CORPUS CHRISTI, Texas The first doses of a COVID-19 vaccine are expected to reach the coastal bend at least by January if not sooner, but the Deputy Coordinator with Nueces County Emergency Management told county commissioners Monday that it will be limited at first with only 25-thousand immunizations expected for the entire state of Texas.
They require at least 1000 doses per location and that is not very many vaccines, said Kathy Ard-Blattner with the Nueces County Emergency Management.
Front line workers from health care to first responders will be the first in line to receive the vaccine, but with an estimated 70-thousand paramedics in the state alone there won't be enough supply to go around on the first attempt.
Right now, Texas is experiencing another surge and is leading the us in positive cases. El Paso seeing the worst of it.
They have had a 1000 percent increase in less than a month of COVID deaths, said Ard-Blattner.
Nueces County is nowhere near that level, but medical professionals stand at the ready as they begin to watch our local numbers increase saying the number of beds and supply levels are still good.
Nueces bed availability 43, out of 121 adult ICU beds are available, said Ard-Blattner.
The county is scheduled to meet with local, regional and state partners on Tuesday to continue their planning for distribution of the vaccine. At least 50 local providers from doctors, pharmacies, to the health department have applied to receive doses.
We are looking at a lot of the major, CVS and Walgreens to be the ones to vaccinate the long-term care and assisted living, said Ard-Blattner.
The vaccine isn't expected to reach the general public until the middle of 2021. Health leaders are also working on informing folks about the vaccination process saying its not like getting a flu shot.
You have to have a 15-minute hold time once you give the vaccination that you have to watch that person for reactions, said Ard-Blattner. It will also require at least 2 doses.
"So, you give a dose, then you have 21-28 days before the second dose is taken, said Ard-Blattner. They expect distribution plans to be finalized by December.
For the latest updates on coronavirus in the Coastal Bend, click here.
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AURORA, Colo. (KDVR) UCHealth University of Colorado Hospital is one of 99 sites across the US that is participating in the Moderna COVID-19 vaccine trial.
More than 200 Colorado volunteers are taking part. Dr. Lisa Wynn and her husband are two of them. Dr. Wynn says they were very excited to hear that early data shows a 94.5% efficacy rate.
Im really excited to be a part of it. This pandemic has really changed the way we live, and I hope that having multiple vaccines that are safe and effective will get us back to living a normal life again, Wynn said.
She and her husband received one injection in August, and another four weeks later. They dont know if they received a placebo, or the actual vaccine. They say they are feeling fine, and have not had any side effects.Dr. Wynn is glad they could do their part to help.
My husband and I are both Black, and it was important for us to patriciate in the trial because diversity in healthcare research is extremely important, she said.
Dr. Thomas Campbell agrees. Hes the Chief Clinical Research Officer at UCHealth who is overseeing the trial.
Dr. Campbell says this vaccine is similar to the Pfizer vaccine, and has similar early data.
When you do two experiments, two scientific experiments and get the same answer you have much greater confidence in the results, Campbell said.
He believes more data is needed on long-term effects of the vaccine, but says people should know that these trials were not rushed.
"We have learned that these colder months when people are clustering inside, the numbers are going to go up," CNN's Chief Medical Correspondent Dr. Sanjay Gupta said Monday night. "Hospitalizations are expected to maybe even hit 100,000."
"We used to talk about the number of people becoming newly infected on any given day hitting 100,000 seemed outrageous. There may be that many people in the hospitals," he added.
Across the country, hospitals are filling up.
In St. Louis, officials announced modeling data suggesting ICU capacity could run out around the first week of December if current rates continue.
"Covid-19 is spreading much too quickly and sending far too many people to our hospitals and intensive care units," incident commander of the St. Louis Metropolitan Pandemic Task Force Dr. Alex Garza said Monday. "We are now at a tipping point. The actions that we take today will determine what the next weeks and months will look like."
And while hundreds of Americans continue to die every day, that number will likely only rise as hospitalizations keep going up, former FDA Commissioner Dr. Mark McClellan told CNN on Monday.
"The problem is that we've got these outbreaks, these hot spot areas where we're approaching health system capacity really all over the country now," he said. "It's not just one part of the country or region."
Preparing for a vaccine
While the high efficacy rates coming out of the Moderna and the Pfizer/BioNTech vaccine trials are a good first step, a vaccine has yet to be approved and experts will also have to decide which groups should get vaccinated first.
An advisory committee to the US Centers for Disease Control and Prevention is scheduled to meet next week to decided who will get the vaccine first, a longtime member of the committee said.
Members of the Advisory Committee on Immunization Practices received notice last week that they'll meet November 23 for five hours, according to committee member Dr. William Schaffner.
Among the first to be vaccinated will likely be health care workers and essential workers, as well as people over age 65 and people with existing health conditions. The question is what order those groups should come in, Schaffner said.
"Health care workers are baked in -- that's the first thing to happen, no doubt about that," he said. But after that, committee members will need to define what underlying conditions would merit getting a vaccine early on and what defines "essential workers" -- a group that could include everyone from police officers to supermarket clerks.
And even once a vaccine is approved and more doses become available, it will be months before the US returns to anything resembling normalcy.
"There's not going to be one day when, you know, the light switch is going to go on and everybody is going be immune," McClellan said. "But we should do a gradually better and better job of containing spread, of avoiding hospitalizations and moving beyond the pandemic in the months to come."
"But we have got a couple of tough months to get through first," he added.
Statewide measures taking effect this week
Guidance for college students returning home
As the Thanksgiving holiday nears, Connecticut Gov. Ned Lamont issued guidance on Monday for out-of-state college students who are planning on returning home to the state for Thanksgiving.
Lamont asked the returning students to self-quarantine for 14 days before or after returning home, get tested for the virus both before leaving school and after getting home, not attend parties or reunions and not quarantine with any elderly or high-risk family members.
"We can't enforce this," he said. "I'm going to have to depend upon your good judgment, ... that you follow the protocols, you follow the quarantine and you follow the testing."
Public health officials and state leaders have repeatedly emphasized how critical the upcoming holidays are and have expressed concern that family and friend gatherings will help fuel an already rampant spread.
"Separation should be the norm," this year, Schaffner also previously urged.
"Less is more this Thanksgiving," he said. "It is the Covid Thanksgiving. We don't want to give the virus while we're giving thanks."
CNN's Lauren Mascarenhas, Elizabeth Cohen, Kelly Christ and Raja Razek contributed to this report.
Clinical data for Moderna's COVID-19 vaccine showed it was nearly 95% effective in preventing disease, according to an interim analysis described in a company release Monday. Maddie Meyer/Getty Images hide caption
Clinical data for Moderna's COVID-19 vaccine showed it was nearly 95% effective in preventing disease, according to an interim analysis described in a company release Monday.
A second COVID-19 vaccine now also appears highly effective in preventing illness following exposure to the virus that causes the disease.
The biotech company Moderna Inc. said Monday that its experimental vaccine was 94.5% effective in preventing disease, according to an analysis of its clinical trial.
The news comes a week after Pfizer and BioNTech said their vaccine was more than 90% effective.
The results for both vaccines come from interim analyses of large clinical studies. In the Moderna study there were 30,000 volunteers. Half got two doses of the vaccine 28 days apart; half got two shots of a placebo on the same schedule.
There were 95 instances of COVID-19 illness among the study participants; only five of those cases were in the vaccinated group. Ninety were in the group receiving the placebo. Of these, there were 11 cases of severe disease. The results indicate the vaccine was inducing the kind of immune response that protects people if they were exposed to the coronavirus.
"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," Stphane Bancel, chief executive officer of Moderna, said in a statement.
Both the Moderna and Pfizer vaccines use the same technology to make their vaccines. It's based on a molecule known as mRNA, or messenger RNA. That molecule contains genetic instructions for making proteins inside cells.
For the vaccine, researchers created an mRNA with the code for making the coronavirus spike protein. The protein is the key to the virus infecting cells. It's also what can trigger someone's immune system to make antibodies against the virus, but without causing infection since the rest of the virus is missing.
That two mRNA vaccines appear to be working is remarkable, since the technology is new and there hasn't been an mRNA vaccine approved by the Food and Drug Administration made to date.
The Moderna and Pfizer studies were conducted using slightly different protocols. To be counted as a COVID-19 case, participants in the Moderna study had to have at least two symptoms of disease in addition to a positive test for the virus. The Pfizer study required only one symptom. Also, Moderna waited 14 days following the second injection to begin counting cases; Pfizer's study started counting at seven days.
The vaccines also differ in their storage requirements. Moderna says its vaccine can be safely stored in freezers at about 25 degrees Fahrenheit (minus 4 degrees Celsius), a temperature easily reached by a home refrigerator freezer. Pfizer's vaccine required storage in specialized ultracold freezers capable of cooling below minus 94 degrees Fahrenheit (minus 70 degrees Celsius). Moderna also says its vaccine will remain potent for up to 30 days at normal refrigerated temperatures, which should ease distribution.
Both companies' vaccine studies managed to recruit a reasonably diverse group of people. Moderna reports 6,000 enrollees who identified as Hispanic or Latinx and more than 3,000 participants who identified as Black or African American, as well as 7,000 people older than 65, and 5,000 with high-risk chronic diseases.
Pfizer and Moderna are still gathering safety data the Food and Drug Administration has said is necessary for consideration of an emergency use authorization that would allow the companies to distribute the vaccine during the pandemic.
Side effects seen for the Moderna vaccine at the interim analysis included pain at the injection site, fatigue and aching muscles and joints. The data safety and monitoring board didn't identify "any significant safety concerns."
Moderna said it intends to file "in the coming weeks" with the FDA for authorization of the company's vaccine for emergency use.
The federal Operation Warp Speed project to hasten development of COVID-19 vaccines awarded Moderna a $1.5 billion contract in August to ramp up manufacturing and deliver 100 million vaccine doses, enough for 50 million people. The government has an option to buy up to 400 million more doses.
Moderna said Monday that it expects to be able to ship about 20 million vaccine doses in the U.S. by the end of 2020. Next year, the company said it expects to be able to make 500 million to 1 billion doses worldwide.
The research and development of the Moderna vaccine was aided by $955 million in federal funding from the Biomedical Advanced Research and Development Authority. Moderna has also been developing this vaccine alongside the National Institute for Allergy and Infectious Diseases, which in July told NPR it expects to spend about $410 million on the effort.
Pfizer and Moderna have both announced promising results in the phase 3 trials of their COVID-19 vaccines. Here's how they differ. Storyful
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.
Heres what we know about both trials and what theymightmean forthe future of the pandemic.
Pfizer and the German biotechnology company BioNTechdeveloped one of the candidate vaccines. They announced early findings of their vaccine, BNT162b2, on Nov. 9.
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.
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/BioNTechwill do a final check of effectiveness when 164 study participants have fallen ill.
Modernas 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.
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.
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 peoples cells into spike protein factories. The spike proteins created by the body arent dangerous because the rest of the virus isnt present, however, the body now sees the protein and designs immune soldiers to fight it upon future exposure.
What a vaccine volunteer has to say: I volunteered for Moderna's COVID vaccine trial. Here's why I think I got the vaccine, not a placebo
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.
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 vaccinesare safe. If someone were to develop a severe vaccine reaction, its likely to happen within six weeks of receiving it. Pfizer will pass that safety milestone this week.Moderna will take longer becauseit 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 its 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 gearshave been oiled up to start cranking out vaccines, scientists have predicted vaccines wont be available to the general public until summer or fall of 2021.
Follow Adrianna Rodriguez and Karen Weintraub on Twitter: @AdriannaUSAT@kweintraub
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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