Florida stands ready to distribute and administer COVID-19 vaccine when its available WFTV Orlando
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Florida stands ready to distribute and administer COVID-19 vaccine when its available - WFTV Orlando
If a vaccine is fast-tracked through an emergency use authorization rather than formally licensed by the Food and Drug Administration, that too could create bureaucratic hurdles. For example, Medicare doesnt cover the costs of emergency-use drugs. So while the government intends to pay the cost of the vaccine and of supplies like syringes, hospitals would be on the hook for storage, scheduling, record keeping, and paying staff to actually give the injections. Hospitals are not happy about thatat all, Behlim says. A fix will likely have to come from Congress.
Another worry for hospitals: having to juggle multiple vaccines that are not interchangeable, especially after more become available in the future. What theyre concerned about is: I get a vaccine now in November, and then another manufacturer launches in January, and then another manufacturer in March, and three more launch in May, Behlim says. Immunization registries can record who got which vaccine, but hospitals and clinics will still have to decide which ones to stock and how much of each. One vaccine might be more effective, but another one easier to store. A third might be most effective in older people, while a fourth could have the advantage of requiring only a single dose. The more vaccines there are on the market, the harder vaccine management becomes.
In fact, with dozens of vaccines currently in clinical trials, the U.S. will very likely have multiple COVID-19 vaccines from multiple manufacturers next year. Two other vaccines are just behind Modernas and Pfizer/BioNTechs mRNA vaccines, in Phase III clinical trials in the U.S. One of those is made by AstraZeneca and the other by Johnson & Johnson; both insert the genetic code for the coronavirus spike protein into a harmless virus.
These vaccines take slightly longer to manufacture, because they require growing viruses, and they are also a relatively new technology. But they do not have to be frozen, and Johnson & Johnsons can be given in just a single dose. Close behind these two are more traditional vaccines that use proteins purified from the virus, which will likely have traditional storage requirements. Of course, clinical trials still need to be completed before scientists will know whether any of these vaccines are safe and effective. Which vaccine or vaccines will prove the safest and the most effective and the most deployable? I think we dont know yet. And thats why having redundancy is good, says Dan Barouch, a vaccine researcher at Harvard. (His lab is a collaborator on Johnson & Johnsons vaccine.)
In the short run, speed is of the essence. But in the long run, these other characteristicssafety, effectiveness, and ease of usewill determine which vaccines get widely distributed. Julie Swann, who studies supply chains at North Carolina State University and who worked with the CDC during the 2009 flu pandemic, says shes disappointed that the U.S. has put its weight behind these mRNA vaccines, which rely on new technology and whose handling imposes extra requirements on states and vaccine providers. It will be even harder to use them in developing countries. Theres no way we can use this in some countries around the world, she says.
The good news is that more deployable vaccines are moving fast through the pipeline too. The race to a vaccine has dominated hopes for an end to the pandemic. But the first COVID-19 vaccine may not ultimately be the most important COVID-19 vaccine.
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COVID-19: The Most Complicated Vaccine Campaign Ever - The Atlantic
It's known as the DSMB.
Members of a Data and Safety Monitoring Board are the only ones who get to look under the hood while a trial is ongoing. They know who has been given a Covid-19 vaccine, and who has gotten a placebo. The very doctors running the trials, the pharmaceutical companies that developed the vaccines, and even the US Food and Drug Administration don't know.
Armed with that secret, only the DSMB can monitor how safe and effective a vaccine is shaping up to be.
One word from the DSMB, and a trial can be stopped. That's what happened to the AstraZeneca trial in early September after a study participant developed neurological symptoms. Shortly after, it came to light that the same trial had been paused briefly in July for similar reasons. While the vaccine trial resumed in the UK, it is still on pause in the US.
"They're very powerful. They're key guardians of science and safety and are as important if not more important than the FDA," said bioethicist Art Caplan.
The need for anonymity
Earlier this year, the National Institutes of Health appointed a common DSMB to monitor Covid-19 vaccine clinical trials that are being funded by the federal government under Operation Warp Speed. This DSMB has 10 to 15 members with specialties including vaccine development, statistics and ethics.
It's not a glamorous or public-facing job. They're paid only a modest honorarium by the NIH -- just $200 per meeting -- and there are no press conferences, no TV interviews, no fame and no glory.
That's because members' names aren't typically revealed while trials are in progress to shield them from external pressures.
Caplan, who has served on about 20 DSMBs, said there's a good reason members' names are kept secret.
"You wouldn't want some investor calling a DSMB member and saying 'Hey, how's this clinical trial looking? If you tell me, I'll give you 10% of whatever I make,'" said Caplan.
Carrie Wolinetz, associate director for science policy at the National Institutes of Health, said various types of people might try to influence DSMB members.
"It doesn't have to be nefarious. Parents of a very ill child might be anxious about how the trial of a drug that could help their child is going, and they might contact the folks at the DSMB. Keeping their names private is a way to preserve independence of the group," she said.
There's a lot at stake. They scrutinize the data carefully. One word from them, and a vaccine's chances of coming to market could be squashed. Millions of dollars spent on research and development could all be for naught.
While there are good arguments for secrecy, Caplan said he disagrees with the confidentiality that currently shrouds the DSMBs for Covid-19 vaccine candidates.
"We need to know if we can trust the vaccine, so the more transparency the better," Caplan said.
"We want to know they're fully independent, that they have no prior relationships with the company. So they're not conflicted in any way," said Dr. Eric Topol, professor of molecular medicine at Scripps Research. "We want to know about their expertise. It's important to know who they are."
How DSMBs work
The job of the DSMB, as the name suggests, is to monitor the data that comes out of clinical trials.
In clinical trials, there can be thousands, or tens of thousands, of study participants. Some are randomly assigned to receive an intervention -- in this case, the vaccine -- and some receive a placebo.
The studies are what's called "double-blinded." The participants don't know which they're getting, and neither do the doctors running the trials.
If a study volunteer has what appears to be a side effect or "adverse event," the DSMB can look and see if they received the vaccine or the placebo.
"If it was a placebo, then it's one of these random things," Susan Ellenberg, a member of Covid-19-related DSMBs, told CNN's Chief Medical Correspondent Dr. Sanjay Gupta. "If it was the vaccine, it could still have been a random thing. But then people have to wring their hands and try and consider how likely is it that the vaccine could cause this kind of event?"
If these events are concerning enough, the DSMB can recommend that the trial be stopped for safety reasons. The stakes are especially high in Covid-19 vaccine trials, which may ultimately be administered to millions of healthy people -- unlike drug trials intended for those who are already sick and may have few options.
"Even an adverse event that happens as infrequently as one in 10,000 people or one in 20,000 people -- that would be a lot of people who would have a serious adverse event," explained Ellenberg, a professor of biostatistics at the Perelman School of Medicine at the University of Pennsylvania.
At pre-determined intervals, the DSMB also checks on efficacy. If people receiving the vaccine get sick roughly as often as those who get the placebo, that's not a good sign. The board can recommend that the trial be stopped due to "futility."
They may also look at the quality of the data, Ellenberg said. If there's missing data, participants who drop out, or if the trial is being conducted poorly, it's the DSMB that can weigh in.
"Most of the time, a data monitoring committee will say, 'Everything looks fine, keep going,' " Ellenberg said. "But sometimes -- you never know when ... a hard decision is going to have to be made. And that's the value of these committees."
Conversely, if it looks like the vaccine is working exceptionally well, the DSMB may recommend that the study sponsor submit an application to the FDA before the official end of the trial, in order to get it more quickly to market.
'Thoroughly vetted'
"The people who serve on these committees are thoroughly vetted for conflicts of interest," Ellenberg said.
Members are screened to make sure they don't have a financial interest in the pharmaceutical company that's sponsoring the vaccine trial.
"DSMB members or their family members should have no professional, proprietary, or financial relationship with the sponsoring companies," according to a statement from the National Institute of Allergy and Infectious Diseases, which organized the common DSMB for the Covid-19 vaccine candidates under Operation Warp Speed -- including Moderna, AstraZeneca and Johnson & Johnson. "Selected DSMB members and their family members were not allowed to work for other companies developing COVID-19 vaccines."
Topol, of Scripps Research, said it's "unprecedented to have a DSMB with that much authority." Typically, each clinical trial has its own DSMB.
Such is the case with Pfizer, whose trial is not neither under the common DSMB nor funded by the government. Pfizer's DSMB comprises "a chairperson and 4 additional members that meets on a weekly basis," according to a spokeswoman.
Topol considers that small for a trial that aims to enroll up to 44,000 participants. "The trials that I ran always had six or seven at least, sometimes eight or nine," he said. "In large trials, you got to have a bioethicist, virologist, an immunologist, epidemiologist... You have all the critical areas covered."
Big honor, but no bragging rights
But it's a no-no to brag about it, as one university recently found out.
The university proudly posted that one of its professors was named chair of the DSMB for the government-supported trials of coronavirus vaccines.
"It looks like a staff member shared that news and was unaware that it was not for public consumption," a university spokesperson wrote to CNN.
CNN is not revealing the professor's name or the name of the university.
Despite the lack of public recognition, fame and glory, Ellenberg says there's plenty of motivation to serve on these boards.
"You feel a great responsibility when you're on these trials," she said. "Everybody's trusting you with these data."
Still, downstream from the DSMB, Ellenberg acknowledges "we're in uncharted territory."
Last week, President Trump claimed the White House can overrule the FDA's attempt to toughen its Covid-19 vaccine guidelines -- guidelines that could push hopes of a vaccine authorization past Election Day.
"It never occurred to anybody that anybody outside the FDA would would try and interfere with that," Ellenberg said. "And I'm hopeful that they won't."
CNN's Sierra Jenkins contributed to this report.
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The secretive group at the center of the nation's largest vaccine trials - CNN
It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important. Wochit
Who will get the coronavirus vaccine as soon as it becomes available is starting to come into focus. A report released Friday breaks the U.S. population into four groups and assigns each a place in line.
Not unexpectedly, people who risk their lives to care for those suffering from COVID-19 the "jump start" group will havefirst dibs, along withpolice, firefighters and paramedics.
The recommendations come from a federal panel working on a fair and just vaccine allocation plan since July. The first group, called Phase 1a, includesfront-line health workers, ambulance drivers,hospital and clinic cleaners andfirst responders about 5% of the total U.S. population.
The National Academies of Sciences, Engineering, and Medicine was tasked with looking at the ethicalquestions associated with distributing a lifesaving vaccine in the midst of a pandemic. The report was requested by the National Institutes of Health and the Centers for Disease Control and Prevention.
The United States already is making millions of doses of COVID-19 vaccine before it's even known which candidate will end up working. Even so, rationing at the beginning will be needed becauseit will take time to getshipping and delivery systems up and running smoothly.When a vaccine or vaccines will be ready isn't know. It could be as soon as November but after the first of the year is most likely, scientists say.
Thepanel's goal is to develop a rollout plan thatmaximizes the benefitto society by focusing on those at highest risk for severe illness or death from COVID-19.
We hope these guidelines serve as the impetus for one of the most consequential peacetime efforts this country has ever seen, said committee co-chair William Foege, emeritus distinguished professor of international health at Emory University and former CDC director.
Ultimately the decision of how coronavirus vaccine will be allocated rests on CDCs Advisory Committee on Immunization Practices, whose guidelines will be informed in part by Fridays report. As soon as the Food and Drug Administration authorizesa new vaccine, the advisory committee offers guidelines on how it should be distributed, to whom and when.
People in Phase 1a arecritical to keeping the health care system functioning and are at high risk of exposure to sick patients. Theyre also at higher risk of then transmitting the virus to others, including family members.
The second phase of vaccine distribution Phase 1b covers about 10% of the population. Itincludes people of all ages with underlying conditions like cancer, serious heart conditions, and sickle cell disease that put them at significantly higher risk of severe COVID-19 disease or death.
This group includes people with two or more chronic conditions that put them at higher risk, including kidney disease, chronic obstructive pulmonary disease, obesity or diabetes.
This phase also includes people 65 and older living in nursing homes, long-term care facilities, homeless shelters, group homes, prisonsor jails.
Phase 2 covers between 30% to 35% of people in United States. It includes teachers, school staff and childcare workers and critical workers in high-risk settings who cant avoid high-risk exposure to COVID-19, such as those working in the food supply system and public transit.
Also included areall people over 65, because theyaccount for about 80% of all reported COVID-19 deaths.
Additionally, those who have one underlying condition that puts them at moderately higher risk, as well as people in homeless shelters or group homesand staff who work in those settings will have access to vaccine in this stage. People under 65 who are in prisons, jails, and detention centers and staffersalso are included.
Phase 3 covers between 40% and 45% of the population. It includes young adultsand people who work in industries such as higher education, hotels, banks, exercise facilitiesand factories.
Whether children are included in this group will depend if COVID-19 vaccines have been tested for safety and efficacy in younger age groups.
Finally, Phase 4 will include everyone elseresiding in the U.S. who did not have access to the vaccine in prior phases, between 5% and 15% of the population.
In these uncertain and challenging times, the integrity of the COVID-19 vaccine development, allocation, and distribution processes will be critical to ensuring widespread access to vaccines that are safe and effective, and convincingly so for the public, said National Academy of Medicine President Victor J. Dzau.
The committee explicitly acknowledged the virus has disproportionally hit Black, Hispanic and Native American communities due to long-standing disparities in access to health care and poverty. In addition, people in these communities often have front-line jobs they cannot do from home, putting them at higher risk for contracting COVID-19.
Because these communities face higher rates of hospitalization and death, the committee recommended special effort be made to deliver vaccine to people in high-vulnerability areas.
At this moment there is an awakening to the power of racism, poverty, and bias in amplifying the health and economic pain and hardship imposed by this pandemic, said committee co-chair Helene Gayle, president and CEO of the Chicago Community Trust.We saw our work as one way to address these wrongs and do our part to work toward a new commitment to promoting health equity."
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September 05, 2020
Its time to talk about flu season. COVID-19 may provide a complication to influenza spread this year as the evidence is mixed.
Weve been following the flu season in the Southern Hemisphere to get an idea of what to expect. The flu season began there in March amid the COVID-19 pandemic. Epidemiologists recently reported in Science magazine that data emerging from places like South Africa, Australia, New Zealand and parts of South America are interesting.
The South African National Institute for Communicable Diseases, or NICD, was prepared for the onslaught of both COVID-19 and influenza. But it never happened.
Typically, NICD surveillance would track 700 cases there. They only logged one case since the end of March. Australias flu season runs from March to August. It listed less than 200 cases, compared to 2,000 this past year.
Most of the cases were probably overshadowed by COVID-19, as many clinics were closed, patients with mild symptoms never went to the doctor or social distancing decreased the numbers. It is unlikely influenza numbers dropped that much. But it happened. Other Southern Hemisphere nations reported similar experiences.
Though the Northern Hemisphere is hopeful for a similar experience, this is unclear. Though flu numbers are currently low, there is the fear that as COVID-19 restrictions are slowly lifted, influenza season will then be upon us. Restrictions may be what depressed influenza numbers in the Southern Hemisphere. Habits such as distancing and hand washing developed during COVID-19 also decrease influenza. It is just unclear if our experience will be the same. There are many concerns to consider either way.
One concern is co-infection. Getting infected with both is worse than getting infected by one. To make things more complicated, getting infected with one may change someones chance of getting infected with the other. Epidemiologists are actually a little concerned about a third virus called Respiratory Syncytial Virus, or RSV, that is also a seasonal pathogen that affects the young and elderly. Having one of these infections may increase the persons susceptibility to other respiratory viruses.
A twindemic of both COVID-19 and influenza is the fear this year. It is for this reason that the Centers for Disease Control and Prevention is recommending that everyone receive the flu vaccine. They also recommend to start getting the shot in September or October before the start of the flu season. The growing concern of two viruses circulating has increased the urgency for vaccinations before Nov. 1.
Influenza simply adds complexity. We still have no idea regarding the trajectory of COVID-19 this winter. Tracking and containing one virus is enough. Two viruses circulating brings uncertainty that vaccines will help mitigate. As communities spend more time indoors during the approaching cooler weather, the risk of transmission heightens for both the flu and COVID-19.
The decreased number of influenza cases in the Southern Hemisphere also decreases the evidence we need regarding the genetic variants that we can expect in the Northern Hemisphere. Viral experts say this creates a genetic bottleneck. The flu variants that survive a record low season will be the most vigorous flu strains.
Vaccines and rapid flu tests have been the workhorses at controlling influenza. Though a rapid COVID-19 test is now available, it may be mid-winter before a COVID-19 vaccine is also available. Vaccinations, testing, containment and prevention strategies will be vital this winter.
No one knows what happens when COVID-19 and influenza collide in the United States. Our flu season generally peaks between December and February. COVID-19 on the other hand doesnt seem to be seasonal as evidenced by increasing cases during the summer.
Influenza is a leading cause of death in nonpandemic years. Differentiating influenza from COVID-19, which has similar symptoms, will be critical to management strategies this winter. People with influenza have never been told to isolate as strictly as those with COVID-19. But this will be one of many challenges faced this season.
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Several issues concerning COVID-19 vaccines need to be addressed - The Robesonian
Many Arizonans remain concerned about COVID-19 and are interested ina vaccine, but sentiments largely are divided alongparty lines, according to a statewide poll conducted this week.
Fifteen percent of Arizonans saidCOVID-19 will be the most important issue facing the next president.
COVID-19 ranked third among 13 issues in the poll, behind bringing the country together and jobs and the economy.
But the response was divided by party. Nearly a third of Democrats,or 31%,said COVID-19 was the top issue for the next president, compared to just 4% of Republicans.
Nearly three-quarters of Arizonans, or 73%, said they will take or consider taking a federally approved COVID-19 vaccine, but most said theyd like to wait until others have taken it rather than taking it right away. That number breaks down to 31.6% who will take it ASAP while 41.6% would wait awhile. Another 18% said they wouldn't take it.
Republicans were more willing to take the vaccine as soon as they can, while more Democrats and independents said they'd "wait awhile until others have taken it," according to the poll.
About 9% of Democrat respondents said they will not take the vaccine, compared to 25% of Republicans and 21% of Independents and other voters.
The Suffolk University/USA TODAY Network poll surveyed 500 likely Arizona voters on issues ranging from the new coronavirus to the November election. The poll was conducted by phone between Saturday and Wednesday.
Poll respondents were split in thirds between registered Democrats, Republicans and independents. Respondents were from across the state and diverse in terms of age, ethnicity and income level.
The poll has a margin of error of plus or minus 4.4 percentage points.
David Hammond, a 36-year-old Democrat from north Phoenix, said he'd like to take the vaccine but wants to wait to "see how it plays out" and to make sure it's been tested enough.
Particularly with the administration in the White House, theyre so damn concerned with getting something out before the election, that Id just be concerned that something is pushed out before its been fully vetted," he said.
James Slagle, 73, said he will take the government-approved vaccine as soon as it's available to him, without a doubt.
Slagle, a registered Republican from Tucson, said as a retired Air Force colonel and negotiator, he knows what the U.S. government is capable of and will certainly take the vaccine. While he said his age plays a factor in his eagerness for a vaccine, he mostly wants to see the country return to business as usual.
Its on everybodys mind, and if it isnt, it should be, he said of the virus. We need to solve this problem and move on with our lives and get our economy back.
If the vaccine was required by the federal government, Arizona residents were a bit more wary. About half those surveyed said theyd take the vaccine, 37%said they wouldnt and 11% said they were undecided.
Described as a "leading candidate" by experts, the vaccine developed by Oxford is starting late stage trials in Arizona. Arizona Republic
Arizonans also weighed in on how President Donald Trump has handled the pandemic response. About 36% of respondents said hes done an excellent or good job while 61% said Trumps approach has been fair or poor.
Arizona had reported 219,212 identified COVID-19 cases and 5,674 known deaths as of Thursday. In July, the state was the national hotspot for spread of the virus.
Arizona hasone of the highest overall rates of COVID-19 infection in the country fifth behind Louisiana, Mississippi, Florida and Alabama as of Thursday.
Arizona's infection rate is 3,047cases per 100,000 people, according to the U.S. Centers for Disease Control and Prevention. The national average is 2,180cases per 100,000 people, though the rates in states hard-hit early on in the pandemic may be an undercount due to a lack of available testing in March and April.
TheCOVID-19 death ratein Arizona was 78per 100,000 people as of Thursday, according to the CDC, putting it 10th in the country in a state ranking that separates New York City and New York state. The U.S. average is 62deaths per 100,000 people, the CDC says.
Reach the reporter at Alison.Steinbach@arizonarepublic.com or at 602-444-4282. Follow her on Twitter @alisteinbach.
Support local journalism.Subscribe to azcentral.com today.
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New Delhi: The much-hyped mass trial of a Chinese coronavirus vaccine in Bangladesh has become uncertain and may even be a non-starter after drugmaker Sinovac Biotech Ltd asked the Hasina government to co-finance the initiative.
Sinovac Biotech Ltd in a letter on September 24 said the trial would be delayed unless the Bangladesh government provided funds, although the company was supposed to bear the costs as per an agreement.
The Beijing-based vaccine giant sent the letter to the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), which was to conduct the trial.
"They [Sinovac] informed us that they would be able to start the trial soon if we co-fund the initiative. We will make a decision after talking to the prime minister," Abdul Mannan, secretary of the health services division at the health ministry, told leading Bangladesh English daily The Daily Star.
We are not dependent on Sinovac. The government is looking for other avenues to get the vaccine right after it is developed," Mannan told The Daily Star.
The Sinovac letter did not mention how much fund it would need and why it was seeking funds at the last moment, according to The Daily Star.
"They probably fulfilled their enrollment criteria for the approval. Now they are placing the financial burden on us," said Prof Sayedur Rahman, member of the ethical review committee of the Bangladesh Medical and Research Council (BMRC).
There is a requirement for human trials on 10,000 to 30,000 people to get any vaccine approved globally, he said.
Prof Nazrul Islam, a member of the National Technical Advisory Committee (NTAC) on Covid-19, said, "This makes everything unclear. We recommended the trials considering the technology transfer, because that would have gotten us the vaccines at a cheaper rate
Bangladeshs pharma major Beximco Pharmaceuticals Ltd (BPL) has agreed to invest with Serum Institute of India Pvt. Ltd (SII) in the effort to bring out an approved vaccine for Covid-19.
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According tothe latestEconomist/YouGov Poll,a quarterof likely votersthink the battle against coronavirus is almost over, believing thatacoronavirus vaccinewillbe available to the public by the end of 2020. One in five (20%) voters say they expect the vaccine by the end of the year, while 5% say theyanticipateitas soon asthe end of next month, November.
The data follows President Trumps claim during Tuesdays debate that a vaccine will be available soon.Ive spoken to Pfizer, Ive spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others...saidthe President. Were weeks away from a vaccine,headded.
This could be the reason whysupporters of PresidentTrumpare more likely than supporters of Democratic presidential candidateJoe Bidentoexpect a COVID-19 vaccine by the end of the year.Two in five (43%) ofthose whointend to vote forTrumpsay they expect a vaccine by the end of the year, compared to13% of those who say they will vote for Biden in the 2020 election.
Trump voters are, in fact, more likely to think that a vaccine is coming this year than next. Just 32% believe the vaccine will become available in 2021.
Votersas awhole tend to thinkthe vaccine is coming in 2021. Theyare most likely toexpect a vaccine by the summer of 2021(41%),with a further13%thinking it wontbe available until the end of 2021.
Only a small proportion of voters(5%)think we will have to wait until 2022 or later for a coronavirus cure.
Related:Vaccination fears rise, especially among Democrats
America Speaks: Will Americans get vaccinated against the coronavirus?
See thetoplinesandcrosstabsfrom this weeksEconomist/YouGov Poll
Methodology:The Economist survey was conducted by YouGov using a nationally representative sample of 1,500 registered voters interviewed online between September 27 30, 2020. This sample was weighted according to gender, age, race, and education based on the American Community Survey, conducted by the US Bureau of the Census, as well as 2016 Presidential vote, registration status, geographic region, and news interest. Respondents were selected from YouGovs opt-in panel to be representative of all US citizens. The margin of error is approximately 3.8% for the overall sample.
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A quarter of voters believe a COVID-19 vaccine will be available by the end of the year - YouGov US
As the race for a COVID-19 vaccine intensifies, San Diego is set to take part in a massive international study of a vaccine developed by drugmaker Johnson & Johnson.
If the news feels like dj vu, thats because its the third COVID-19 vaccine trial to reach San Diego, joining studies led by Massachusetts biotech Moderna and British pharma giant AstraZeneca.
The international trial will enroll 60,000 participants across 34 U.S. states and 10 countries, from Mexico and Argentina to South Africa to the Philippines.
Local researchers aim to enroll 3,000 to 3,500 San Diegans. That includes 2,000 volunteers at UC San Diego and 1,000 to 1,500 at M3 Wake Research, an organization that provides clinical research facilities and services.
M3 Wake Researchs site is in the city of San Diego. UCSDs will be in National City rather than its Hillcrest or La Jolla medical centers to make the trial accessible to South Bay communities that have been hit hard by the pandemic.
I think it is critical that we expand the participation in these (vaccine) studies, all of them, to reflect the racial and ethnic diversity of the United States, said Dr. Susan Little, director of the UCSD site.
The trial is open to healthy adults 18 and up, including those who have underlying conditions such as diabetes or heart disease but are in stable condition.
To be eligible, you cant already have had COVID-19. If you were to vaccinate those who already had the disease, youd never know if they were protected by their previous immune response or by the vaccine.
But vaccinate people who will never be exposed to the virus, and youll also never know whether the vaccine worked. Thats why these trials are so large so that enough participants get exposed to the coronavirus for researchers to know whether a vaccine works.
Half of the trial participants will get a single injection of the vaccine, while the other half get a saltwater placebo injection. Who gets the vaccine or placebo will be assigned at random.
Everyone will then be monitored for COVID-19 symptoms. The Food and Drug Administration has stated that any vaccine must prevent COVID-19 or reduce its severity in at least 50 percent of people to get emergency use authorization. Johnson & Johnson aims to show that its vaccine is 60 percent effective.
Results from this and other ongoing trials will be reviewed by an independent team of researchers not affiliated with the vaccine developer or the FDA. These boards can recommend that a study be stopped early if theres clear evidence that a vaccine is safe and effective or if theres cause for concern.
An example of the latter occurred in early September when AstraZenecas trial was halted after a U.K. participant who received the vaccine showed symptoms of spinal inflammation. No San Diegans were vaccinated in AstraZenecas trial before the pause.
That trial has since resumed in the U.K., though it is still paused in the U.S., in part because the FDA has asked for extensive documentation on exactly what happened, says Little.
This should give people confidence that no safety steps are being skipped, Little said. The safety of vaccine study participants remains paramount.
Public polling shows that many Americans believe the vaccine process has been polluted by politics, and with the November election looming, President Trump has said that he believes the nation is weeks away from having a vaccine.
In response to the controversy and confusion, several vaccine developers have openly shared their trial protocols. In Johnson & Johnsons case, the independent monitoring board wont even begin to look for signs the vaccine is safe and effective until half of all participants have been monitored for two months.
The trial launched Sept. 23, meaning even the earliest indications of vaccine efficacy wont come until well after election day.
The companys vaccine uses a harmless virus that has been tested in HIV, Zika and Ebola vaccine studies to carry instructions that teach the human body to target the surface of the novel coronavirus. Results released online from an early-stage study of the vaccine showed that it was safe overall, mostly causing a bit of soreness around the injection site, and triggered immune responses with the potential to block the coronavirus and target infected cells.
How can I sign up or learn more?
M3 Wake Research: Call or text COVID to 619-330-0756. Or visit http://www.covidstudies.org.
UCSD: Visit http://www.covidvaccinesd.com or call 619-742-0433.
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A New Albany family experienced the good and bad of a COVID-19 vaccine clinical trial Courier Journal
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