The Covid-19 pandemic is currently unfolding in one big wave with no evidence that it follows seasonal variations common to influenza and other coronaviruses, such as the common cold, the World Health Organization has warned.
Amid continued debates over what constitutes a second wave, a resurgence or seasonal return of the disease, Margaret Harris, a WHO spokesperson, insisted that these discussions are not a helpful way to understand the spread of the disease.
People are still thinking about seasons. What we all need to get our heads around is this is a new virus and this one is behaving differently, Harris told a virtual briefing in Geneva, urging vigilance in applying measures to slow transmission that appears to be accelerated by mass gatherings.
She also warned against thinking in terms of virus waves, saying: Its going to be one big wave. Its going to go up and down a bit. The best thing is to flatten it and turn it into just something lapping at your feet.
The reality is that the issue of second waves has been a contentious one, much talked about by politicians including Boris Johnson and the media, but often very ill-defined.
With no agreed-upon scientific definition, the term second wave has been used to mean anything from localised spikes in infection to full-blown national crises, leading some experts to avoid it.
Second wave isnt a term that we would use [in epidemiology] at the current time, as the virus hasnt gone away, its in our population, it has spread to 188 countries so far, and what we are seeing now is essentially localised spikes or a localised return of a large number of cases, said Linda Bauld, professor of public health at the University of Edinburgh.
Tom Frieden, former director of the US Centers for Disease Control, is among those arguing that the concept is unhelpful for implying that Covid-19 will act as the flu acts.
Complicating the issue is perspective. Seen from a global viewpoint such as that of the WHO the pandemic appears as a single, large and still-accelerating outbreak, with worldwide numbers doubling in the past six weeks.
In terms of regional spread and even within individual countries, from a ground-level view, it becomes more complicated.
What can appear like a second wave is sometimes different areas of the same country simply being out of phase with each other in experiencing the epidemic, as in the US where a strong but uneven first wave moved initially in fits and starts and then more quickly.
Keith Neal, emeritus professor in the epidemiology of infectious diseases at the University of Nottingham, said that it has become a media term, as well as a scientific one.
What we are seeing are spikes in many countries, and in Leicester [in the UK] and other places. Some people might call these waves but if they do we are looking at dozens of waves.
Even in Australia [in Victoria] there is clearly an upturn but the disease was only at low levels to start with, so its down to a vague terminology.
As Melissa Hawkins, a professor of health at American University, wrote in the Conversation, looking at the US situation, talking about second waves in countries where the disease has simply progressed unevenly is inappropriate.
The US as a whole is not in a second wave because the first wave never really stopped. The virus is simply spreading into new populations or resurging in places that let down their guard too soon, she wrote, a comment applicable to other countries that have seen resurgences.
As the University of Oxfords Centre for Evidence-Based Medicine, which examined 10 epidemics of respiratory disease from 1889, points out: Most of our thinking on second-wave theory arises from the 1918-20 Spanish flu that infected 500 million people worldwide and reportedly killed an estimated 20 million to 50 million.
Waves imply a lack of viral circulation which is probably an illusion, wrote Tom Jefferson and Carl Heneghan early in the outbreak in the UK.
Waves are also visible and mostly rhythmical. There does not appear to be any pattern or rhythm to the epidemics summarised in the table and their comings and going are only visible because of the effects on the human body and their impact on society.
The disease has little respect for land borders, even when authorities have tried to seal them; perhaps the only country that appears to have entirely stamped out the disease is New Zealand, an island nation that has curtailed almost all inbound travel.
More important than the description of any rise in cases is public health management of the increase, Neal added, and he cautioned that identifying a true second wave may need the perspective of time.
It is defining when we have [a second wave] that is the issue. In the Spanish flu it was quite apparent. But only after the event.
The WHO is looking at world figures and these are still increasing so as a pandemic we are in the first wave.
AUSTIN, Texas The only antiviral drug currently used to treat SARS-CoV-2, the coronavirus that causes COVID-19, is remdesivir, but administering it is invasive and challenging. Scientists at The University of Texas at Austin are hoping to change that by using their novel thin-film-freezing technology to deliver remdesivir through dry powder inhalation, potentially making treatment more potent, easier to administer and more broadly available.
A team of researchers in UT Austins Division of Molecular Pharmaceutics and Drug Delivery, led by Robert O. (Bill) Williams III, has investigated varying methods of drug delivery to repurpose existing drugs into more efficacious forms. Earlier this year, the team focused on niclosamide, confirmed to exhibit antiviral efficacy in COVID-19 infected cells. Since then, remdesivir has emerged as the only available antiviral treatment for coronavirus.
Remdesivir is authorized for emergency use in adult and pediatric patients hospitalized with severe disease. Originally developed to treat the Ebola virus disease, remdesivir has shown promising results treating COVID-19 in the human airway epithelial cells. However, limited effective delivery methods have hindered efforts to provide widespread treatment to a broad range of patients exhibiting life-threatening symptoms.
Unfortunately, remdesivir is not suitable for oral delivery since the drug is mostly metabolized by the body, Williams said. Intramuscular injection also faces challenges, since release rates from the muscles can vary widely.
To provide remdesivir for other patients beyond the most severely ill, more convenient and accessible dosage forms for different routes of administration must be quickly developed and tested so patients have more options to get treated. One way to overcome the poor absorption rates of remdesivir is to deliver it directly to the infection site. The research team, which includes Sawittree Sahakijpijarn, Chaeho Moon and John J. Koleng, has developed inhaled forms of remdesivir for protecting and treating the respiratory mode of infection, including an amorphous brittle matrix powder made by thin-film freezing. Not only would this delivery method allow for wider distribution of an essential antiviral in the fight against COVID-19, it could also make remdesivir more effective.
If patients can avoid a hospital visit to begin remdesivir treatment, it can lessen the current strains on our health system, lower cost and provide fewer points of contact with those who are still contagious, Williams said. More widely available early stage intervention methods could significantly lesson symptoms before they become potentially life-threatening, providing more hospital beds and ventilators to those who need them the most.
TFF Pharmaceuticals Inc. has acquired the patents regarding thin-film freezing and inhalation. The UT researchers findings were recently published as a preprint in bioRxiv. Upon final study results, the team will submit its full findings for peer review and publication.
Media Advisory
Tuesday, July 28, 2020
Two doses of an experimental vaccine to prevent coronavirus disease 2019 (COVID-19) induced robust immune responses and rapidly controlled the coronavirus in the upper and lower airways of rhesus macaques exposed to SARS-CoV-2, report scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19.
The candidate vaccine, mRNA-1273, was co-developed by scientists at the NIAID Vaccine Research Center and at Moderna, Inc., Cambridge, Massachusetts. The animal study results published online today in the New England Journal of Medicine complement recently reported interim results from an NIAID-sponsored Phase 1 clinical trial of mRNA-1273. The candidate mRNA-1273 vaccine is manufactured by Moderna.
In this study, three groups of eight rhesus macaques received two injections of 10 or 100 micrograms (g) of mRNA-1273 or a placebo. Injections were spaced 28 days apart. Vaccinated macaques produced high levels of neutralizing antibodies directed at the surface spike protein used by SARS-CoV-2 to attach to and enter cells. Notably, say the investigators, animals receiving the 10-g or 100-g dose vaccine candidate produced neutralizing antibodies in the blood at levels well above those found in people who recovered from COVID-19.
The experimental vaccine also induced Th1 T-cell responses but not Th2 responses. Induction of Th2 responses has been associated with a phenomenon called vaccine-associated enhancement of respiratory disease (VAERD). Vaccine-induced Th1 responses have not been associated with VAERD for other respiratory diseases. In addition, the experimental vaccine induced T follicular helper T-cell responses that may have contributed to the robust antibody response.
Four weeks after the second injection, all the macaques were exposed to SARS-CoV-2 via both the nose and the lungs. Remarkably, after two days, no replicating virus was detectable in the lungs of seven out of eight of the macaques in both vaccinated groups, while all eight placebo-injected animals continued to have replicating virus in the lung. Moreover, none of the eight macaques vaccinated with 100 g of mRNA-1273 had detectable virus in their noses two days after virus exposure. This is the first time an experimental COVID-19 vaccine tested in nonhuman primates has been shown to produce such rapid viral control in the upper airway, the investigators note. A COVID-19 vaccine that reduces viral replication in the lungs would limit disease in the individual, while reducing shedding in the upper airway would potentially lessen transmission of SARS-CoV-2 and consequently reduce the spread of disease, they add.
KS Corbett et al. Evaluation of the mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates. New England Journal of Medicine DOI: 10.1056/NEJMoa2024671 (2020).
NIAID Director Anthony S. Fauci, M.D., Barney S. Graham, M.D., Ph.D., deputy director, VRC, NIAID, and Robert Seder, M.D., chief, Cellular Immunity Section, VRC, NIAID, are available to discuss this paper.
NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIHTurning Discovery Into Health
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The worlds biggest COVID-19 vaccine study got underway Monday with the first of 30,000 planned volunteers helping to test shots created by the U.S. government one of several candidates in the final stretch of the global vaccine race.
Theres still no guarantee that theexperimental vaccine, developed by the National Institutes of Health and Cambridge-based Moderna Inc., will really protect.
The needed proof: Volunteers wont know if theyre getting the real shot or a dummy version. After two doses, scientists will closely track which group experiences more infections as they go about their daily routines, especially in areas where the virus still is spreading unchecked.
Unfortunately for the United States of America, we have plenty of infections right now to get that answer, NIHs Dr. Anthony Fauci recently told The Associated Press.
Moderna said the vaccination was done in Savannah, Georgia, the first site to get underway among more than seven dozen trial sites scattered around the country.
Several other vaccines made by China and by Britains Oxford University earlier this month began smaller final-stage tests in Brazil and other hard-hit countries.
But the U.S. requires its own tests of any vaccine that might be used in the country and has set a high bar: Every month through fall, the government-funded COVID-19 Prevention Network will roll out a new study of a leading candidate each one with 30,000 newly recruited volunteers.
The massive studies arent just to test if the shots work theyre needed to check each potential vaccines safety. And following the same study rules will let scientists eventually compare all the shots.
Next up in August, the final study of the Oxford shot begins, followed by plans to test a candidate from Johnson & Johnson in September and Novavax in October if all goes according to schedule. Pfizer Inc. plans its own 30,000-person study this summer.
Thats a stunning number of people needed to roll up their sleeves for science. But in recent weeks, more than 150,000 Americans filled out an onlineregistrysignaling interest, said Dr. Larry Corey, a virologist with the Fred Hutchinson Cancer Research Institute in Seattle, who helps oversee the study sites.
These trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population, Corey told a vaccine meeting last week. He stressed that its especially important to ensure enough Black and Hispanic participants as those populations are hard-hit by COVID-19.
It normally takes years to create a new vaccine from scratch, but scientists are setting speed records this time around, spurred by knowledge that vaccination is the worlds best hope against the pandemic. The coronavirus wasnt even known to exist before late December, and vaccine makers sprang into action Jan. 10 when China shared the virus genetic sequence.
Just 65 days later in March, the NIH-made vaccine wastested in people. The first recipient is encouraging others to volunteer now.
We all feel so helpless right now. Theres very little that we can do to combat this virus. And being able to participate in this trial has given me a sense of, that Im doing something, Jennifer Haller of Seattle told the AP. Be prepared for a lot of questions from your friends and family about how its going, and a lot of thank-yous.
That first-stage study that included Haller and 44 others showed the shots revved up volunteers immune systems in ways scientists expect will be protective, with some minor side effects such as a brief fever, chills and pain at the injection site. Early testing of other leading candidates have had similarly encouraging results.
If everything goes right with the final studies, it still will take months for the first data to trickle in from the Moderna test, followed by the Oxford one.
Governments around the world are trying to stockpile millions of doses of those leading candidates so if and when regulators approve one or more vaccines, immunizations can begin immediately. But the first available doses will be rationed, presumably reserved for people at highest risk from the virus.
Were optimistic, cautiously optimistic that the vaccine will work and that toward the end of the year there will be data to prove it, Dr. Stephen Hoge, president of Moderna, told a House subcommittee last week.
Until then, Haller, the volunteer vaccinated back in March, wears a mask in public and takes the same distancing precautions advised for everyone while hoping that one of the shots in the pipeline pans out.
I dont know what the chances are that this is the exact right vaccine. But thank goodness that there are so many others out there battling this right now, she said.
AP photographer Ted Warren in Seattle contributed to this report.
There are close to 200 COVID-19 vaccines in testing around the world. So far, two have shown positive results. But is competition good?
CHARLOTTE, N.C. Dozens of companies in multiple countries are racing to develop a COVID-19 vaccine but it turns out, when a vaccine does become available, some healthy competition in the market is not what we need.
Global competition for a coronavirus vaccine could spark another problem: Who gets it first?
There are close to 200 vaccines in development stages around the world. So far, at least two of those vaccines have triggered an immune response in clinical trials. Here's the problem with it. One of those vaccines is being worked on by British scientists and the United Kingdom has already paid for the first 100 million doses produced.
Meanwhile, the United States has made a deal with Pfizer to get 100 million doses of its vaccine. This all works in countries with the money to handle a massive undertaking like vaccine research and development, but there are plenty of countries that don't have the resources. It's not just their problem, either.
As we've learned, coronavirus doesn't respect borders. An ongoing outbreak in one country can be a threat to the entire world if untreated. Public health experts warn that we need to come up with a plan to make sure everyone has access to a vaccine to end the COVID-19 threat to us all.
The worlds biggest COVID-19 vaccine study got underway Monday with the first of 30,000 planned volunteers helping to test shots created by the U.S. government one of several candidates in the final stretch of the global vaccine race.
Theres still no guarantee that the experimental vaccine, developed by the National Institutes of Health and Moderna Inc., will really protect.
The needed proof: Volunteers wont know if theyre getting the real shot or a dummy version. After two doses, scientists will closely track which group experiences more infections as they go about their daily routines, especially in areas where the virus still is spreading unchecked.
Unfortunately for the United States of America, we have plenty of infections right now to get that answer, NIHs Dr. Anthony Fauci recently told The Associated Press.
Moderna said the vaccination was done in Savannah, Georgia, the first site to get underway among more than seven dozen trial sites scattered around the country.
Several other vaccines made by China and by Britains Oxford University earlier this month began smaller final-stage tests in Brazil and other hard-hit countries.
But the U.S. requires its own tests of any vaccine that might be used in the country and has set a high bar: Every month through fall, the government-funded COVID-19 Prevention Network will roll out a new study of a leading candidate each one with 30,000 newly recruited volunteers.
The massive studies arent just to test if the shots work theyre needed to check each potential vaccines safety. And following the same study rules will let scientists eventually compare all the shots.
Next up in August, the final study of the Oxford shot begins, followed by plans to test a candidate from Johnson & Johnson in September and Novavax in October if all goes according to schedule. Pfizer Inc. plans its own 30,000-person study this summer.
Thats a stunning number of people needed to roll up their sleeves for science. But in recent weeks, more than 150,000 Americans filled out an online registry signaling interest, said Dr. Larry Corey, a virologist with the Fred Hutchinson Cancer Research Institute in Seattle, who helps oversee the study sites.
These trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population, Corey told a vaccine meeting last week. He stressed that its especially important to ensure enough Black and Hispanic participants as those populations are hard-hit by COVID-19.
It normally takes years to create a new vaccine from scratch, but scientists are setting speed records this time around, spurred by knowledge that vaccination is the worlds best hope against the pandemic. The coronavirus wasnt even known to exist before late December, and vaccine makers sprang into action Jan. 10 when China shared the virus genetic sequence.
Just 65 days later in March, the NIH-made vaccine was tested in people. The first recipient is encouraging others to volunteer now.
We all feel so helpless right now. Theres very little that we can do to combat this virus. And being able to participate in this trial has given me a sense of, that Im doing something, Jennifer Haller of Seattle told the AP. Be prepared for a lot of questions from your friends and family about how its going, and a lot of thank-yous.
That first-stage study that included Haller and 44 others showed the shots revved up volunteers immune systems in ways scientists expect will be protective, with some minor side effects such as a brief fever, chills and pain at the injection site. Early testing of other leading candidates have had similarly encouraging results.
If everything goes right with the final studies, it still will take months for the first data to trickle in from the Moderna test, followed by the Oxford one.
Governments around the world are trying to stockpile millions of doses of those leading candidates so if and when regulators approve one or more vaccines, immunizations can begin immediately. But the first available doses will be rationed, presumably reserved for people at highest risk from the virus.
Were optimistic, cautiously optimistic that the vaccine will work and that toward the end of the year there will be data to prove it, Dr. Stephen Hoge, president of Massachusetts-based Moderna, told a House subcommittee last week.
Until then, Haller, the volunteer vaccinated back in March, wears a mask in public and takes the same distancing precautions advised for everyone while hoping that one of the shots in the pipeline pans out.
I dont know what the chances are that this is the exact right vaccine. But thank goodness that there are so many others out there battling this right now, she said.
AP photographer Ted Warren in Seattle contributed to this report.
Anna Lunaria says she wouldn't usually consider signing up for clinical trials of new drugs or vaccines.
But last week, shevolunteered to participate in the first late-stageCOVID-19 vaccine trials in Arizona, despite the potential risks as a test subject.
"I'mnot afraid of a vaccine. I'm afraid of the virus," said Lunaria, aPhoenix acupuncturist. "I think of it as my patriotic duty to do what I can in this time."
American biotech company Moderna and American pharmaceutical giant Pfizer both launchedlate-stage trials of their respectivevaccines on Monday. Thevaccines haveemerged at a breakneck speed and haveshown promise in earlier studies.
The federal government has announced a goal of delivering 300 million doses of a safe, effective vaccine for COVID-19 by January 2021in a plan called Operation Warp Speed.
If early results from eithertrial look good, avaccine could be fast-tracked for approval, but it's unclear who would initially receive the vaccine if it's approved.
Four Arizona sites are participating in Moderna's nationwide trial, none affiliated with hospitals or research universities. Threesites are at a private research company calledthe Hope Research Institute, with locations in Chandler, Peoria and Phoenix. The fourth is at the Quality of Life Medical and Research Center, a private health care provider and research center basedin Tucson.
The Phoenix Hope Research Institute location will alsoparticipate inthe Pfizer trial, along with a private clinical research company in Tempe called theClinical Research Consortium.
Bothtrials will enroll 30,000 participantsand are meantto be a final testof the vaccine's safety and effectiveness.
The results are expected to be reviewedby drug regulators like the Food and Drug Administration for potential vaccine approval.
The trials willfollow participants for two years after they are injected as they live their normal lives, with regular check-ups to measure participants' immune system responses. Because of pressure to make a vaccine quickly,it's possible either vaccine could be released well ahead of the formal conclusionof the studies.
Early data from Moderna vaccine trials looks encouraging, company officials said. Vaccinated participants generated more neutralizing antibodies than have been seen in most recovered COVID-19 patients. The study results reflect45 participants, all of whom were under the age of 55 and most of whom were white.
There were some reported side effects in the study, which varied depending on the dosage. While no one who received a mild dose experienced fever, six participants in the moderate dosing group experienced fever, along witheight in the high dosing group, including one who had to be hospitalized.
Pfizer is continuing to collect data from earlier studies but said in a press release that preliminary results based on nearly 120 patientsshowed the vaccine was able to produce antibodies that could neutralize the virusin all patients with generally mild to moderateand temporary side effects such as fever, fatigue and chills.
Earlier data from the first 45 patients showed that the rate of fevergrew more common in patients who received higher doses. After a second dose of the vaccine, 75% of patients in a moderate dosing group experienced fever.
Bill Gruber, the Pfizersenior vice president ofvaccine clinical research and development, declined to give an exact demographic breakdownof early study groups, but said a small percentage of participants were from minority groups.
For some, thesetypes of side effects and study limitations, coupled with the rapid pace of vaccine development, raises concerns.
"Any time that we try to accelerate the discovery process, we run the riskof cutting corners," saidJason Robert, an Arizona State University bioethicist who focuses on how to practice safe and ethical science.
Before signing up for any COVID-19 study, Robertcautions that peopleshould fully understand the risks and shouldn't volunteerfor the wrong reasons.
"Scientists are doing this for the good of the whole, not the individual," he said. "It might be our civic dutyto participate in these studies, but don't do it because you think you're going to get better."
Only some trial participants will receive actual vaccines. Others will receive placebo injections instead, allowingresearchers tocompare the results.
This means if a participant receives a placebo instead of a vaccine, they may be giving up their chance to get a vaccine right away if a vaccine is approved sooner.
Both studies areblinded, meaningparticipants will not know whether they have received the vaccine or the placebo. This is done to avoid any potential bias in the data.
There is some potential risk for participants, said Jack McGettigan, the doctor who is overseeing Moderna's trial in Tucson.If there are any side effects, McGettigan said he expects to see mild fevers or body aches,which typically disappear quickly.
He hasn't seen indications of significant problems, "butyou don't know until you do the actual study," he said.
He wishes to enroll at least 300 participants at his trial location.
"I'm hopingjust to domy best to get patients in as quick as possible, because the quicker we get them in, the sooner we'll get results," he said.
There's no guarantee the vaccine will be successful, he said. "There's just hope."
Clinical trial participants haven't always reflected broader populationsand have skewed towardhealthier, young white males, but this is something many researchers are trying to change.
For COVID-19 vaccine trials, the FDA has issued guidance that "strongly encourages the enrollment of populations most affected by COVID-19, specifically racial and ethnic minorities," and has encouraged the inclusion of other high-risk groups such as those with underlying diseases in late-stage vaccine trials as well as pregnant women or women of child-bearing age.
The inclusion of these groups can have important implications for understanding how a treatment may affect various groups differently, since genetics or other factors influence how well a treatment works.
A poster is displayed in the entrance way looking for volunteers as the world's biggest study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., gets underway Monday, July 27, 2020, in Binghamton, N.Y. (AP Photo/Hans Pennink)(Photo: Hans Pennink, AP)
Both trials excludepregnant women and those with certain immune disorders. McGettigan said he is trying to enroll racial minorities and other higher-risk groups for Moderna's trial by reaching out to the Hispanic community and local tribes.
"There's evidence that shows that COVID-19 affects different races differently so it's very important to have strong minority representation in the study," said NathanAlderson, the CEO of the Hope Research Institute.
Enrolling diversepatients can be a challenge, according to Gruber.
"It is somewhat challengingin some instances to get into those communities and there's a lot of work that we're doing to provide a reassurance to those communities about the safety of vaccines," he said.
Of the Arizona sites for both vaccine trials, the Quality of Life Medical Research Center is the only one enrolling Spanish-speaking participants. The rest only accept English-speaking participants.
Towler said he expects to enroll up to 200 participantsat the Clinical Research Consortium trial site; 108 participants have already enrolled.
The Hope Research Institutewill enroll as many eligible participants as possible, first come, first served.
"We're really excited to bring these trials to the Phoenix area and do our part to accelerate these trials towards potential approval," Alderson said."It's astounding to see the industry move this fast."
ASU bioethicist Ben Hurlburt acknowledges that this pandemic is a public health emergency requiring aspeedy response, but said there is a danger in latching on to promising treatments too quickly.
"There's a hunger for answers, fast answers," he said. "There's maybe less attention to the provisionalities and nuances of those answers."
Vaccine development is often a long and complicated processand it typically takes over 10 years to getvaccine approval. Determininglong-term side effects or effectiveness takes years, and researchers must clear many regulatory hurdles.
Some of those hurdles are being taken away, according to Robert. Moderna, for example,was not initially required to do animal model tests of its vaccines before testingin humans.
"That's an example of jumping over a step in the vaccine development process," he said. "That could be potentially problematic."
Some researchers argue that speeding up the process is necessary.
"This is apandemic of unprecedented magnitude that we haven't seen for a hundred years or so. Wedon't want to sit around and pontificate," McGettigan said.
Gruber saidthe notion that drug or vaccine developers are cutting corners is a misconception, and attributes the speed to greater regulatory efficiency.
Where it used to take months to get studies reviewed for approval, he said, it now takes days.
He said Pfizer is still using the same criteria in its development process, which is why initial vaccine trials were only tested in a small number of people to check for safety before moving onto larger tests.
McGettigan also argues that the science behind making vaccines has accelerated rapidly, allowing researchers to move quicker than ever before.
BothModerna's and Pfizer'scandidates are a new type of vaccine. Traditional vaccines rely on injecting patients with inactivated virusor some other agent that resembles the virusto help train the body's immune system to recognize the virus's shapeand develop antibodies to neutralize it.
The world's biggest COVID-19 vaccine test got underway Monday with the first of 30,000 planned volunteers. The experimental vaccine is made by the National Institutes of Health and Moderna Inc. It's one of several candidates in the vaccine race. (July 27) AP Domestic
The Moderna and Pfizer vaccines are mRNA vaccines, meaning they relyon injecting patients with parts of the virus's genetic code, known as RNA.
Each company'sCOVID-19 vaccine focuses on the part of the virus's genetic code that is responsible for creating the spikes on the outside of the virus that allowit to infect cells. When injected into a patient, the genetic codeacts like a set of instructions given to the host cell and causes the host cellto start producing the spikes, but not the rest of the virus.
In this form, with just the spikes, the virus is not infectious, but in theory, the presence of the spikes will stilltrain the immune system to recognize and fight future COVID-19 infections.
Such vaccines are easier and quicker to produce than traditional vaccines, buthave never been approved for use by the FDA.
"The beauty of them is that they can make a lot of vaccine much more quickly thanthe old techniques. The biggest downside right now is ithas not ever been proven to be an effective vaccine because it's so new," McGettigan said.
Even if its vaccine is approved,Pfizer will continue to tweak itto improve safety and efficacy, according to Gruber. Pfizer will try to lower the dosage needed to get protection, he said.
"This could be a watershed moment not just for COVID-19 but this could be applied for other pathogens," he said, explaining that Pfizer is also testing this approach for the influenza vaccine.
Earlier this month, the U.S. governmentagreed to payPfizer $1.95 billion to secure 100 million doses of the vaccine that can be given to the public for free if it is approved.
While Pfizer isa well-established pharmaceutical giant, Moderna was a relatively new, unknown company and hadnever developed an FDA-approved drug. Modernahas received nearly $1 billion from the federal government for its vaccine development efforts.
The Moderna mRNA vaccine does not cause any more reactions than many already-licensed vaccines,according to the National Institute of Allergy and Infectious Diseases, which said the side effects are "mild or moderate."
Another big question that needs to be answered is whether antibodies provide long-term immunity, Alderson said. If they don't, it'spossible that vaccines will need to be administered annually.
"There's no good datato show how long antibodies will last," he said.
It's not just about antibodies though, according to Gruber. Other immune cells, such as memory T-cells, which are trained to recognize viruses, can be important for long-term immunity, which is why Pfizer is also measuring the levels of these cells in trial participants.
So far, he said Pfizer is seeing a robust immune system response to their vaccineand has measured good response levels of other cells such asmemory T-cells.
That'sbecause Pfizer is using a large section of the virus'genetic code in their vaccine, he said, which can have important implications for broad-spectrum protection.
"We have more potential parts ...for the immune system to recognize," he said. "Given that not all of us recognize every little piece of a foreign agent like a virus, this maximizes our potential, across adiversity of racial and ethnic groups, ages, and geographical locations, that we'llbe more likely to provide protection."
The National Institute of Allergy and Infectious Diseases said that "durability of protection will have to be answered experimentally," and addedthat the possibility of the virus mutating in a way that renders a vaccine ineffective in the long term is not a current concern.
McGettigan said not everyone is a good fit for research, but heconsiders those who are volunteering to be medical heroes.
"They are willing to take a risk," he said. "It's a lot of altruism. There are people who are willing to step up for their fellow humans and take the first shot."
One such potential volunteer is Natarajan Ganesan,a biomedical researcher who has previously worked with the infectious diseases institute. As a former researcher, Ganesan has no illusions about the vaccine and is aware of the risks.
"Is it promising? I won't say that, but I won't play it down either," he said. "Phase three is really when the rubber meets the road and when we really get to test the vaccine."
Even with the unknowns, study locations say they are taking steps to make trials as safe as possible, and both trialsare monitoring for serious side effects in real time.
This allowsstudies to be shut down quickly across all locations if there is a cause for concern.
The intense monitoring of side effectsmakes Phoenix resident Candice Fremouw sometimes feel more comfortable with clinical studies than treatments at the doctor's office.
Fremouw says she has participated in six studies in the past, including vaccine studies, andhas now signed up as a potential volunteer for the Moderna trials.
"I feel comfortable," she said. "They're so tightly supervised."
Gruber said the Pfizer trials will be extremely rigorous in checking for side effects, but that he isn't worried.
"I think there is essentially a zero chance that we would be seeing any untoward safety events that would slow us down," he said. "But that doesn't keep us from looking really hard to make sure we don't miss one."
Fremouw is confident in the trials because she has takennew vaccines in the past.
"I remember standing in line for sugar cubes for polio," said Fremouw, who's 64 and retired."We've done this before."
Even if a vaccine turns out to be safe and effective, Robertsayspeople should approach study results with cautionandhold off on making any travel plans on the promise of a vaccine byspring.
With many people desperate for a cure andcompanies vying for the spotlight and money that comes with producing a successful vaccine, he said it can be easy to over-hype the promise of any vaccine.
"This is a process, and it's a marathon, not a sprint," Robert said. "A safe and effective vaccine isn't necessarily going to be the be all and end all of this."
It's still unclear whether a vaccine will provide long-term immunity or whether different vaccines will be needed for different strains of the new coronavirus.
FDA guidelines state that vaccines should aim to be at least 50% moreeffective in providing protection compared toa non-vaccinated personto "ensure that a widely deployed COVID-19 vaccine is effective."
The FDA did not respond to further questions about the vaccine approval process, but Gruber saidPfizerexpects to be able to show over 50% efficacy by October. He said thetimeline could be affected if the pandemic slows down and there is less enrollment as a result.
It's still possible for both vaccines to fail. If that happens, the vaccines may never hit the market. The window of success can be small, Towler said.
Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY
Still, Towler remains optimistic that someone will succeed with so many different companies and researchers working toward this goal.
"They will have something that comes through with positive results," he said. "We're not just hedging our bets on one option."
There also may be manufacturing and distribution issues that slow down the goal of herd immunity.
Modernahas saidit is on track to manufacture and deliver500 millionto 1 billion doses of the vaccine per year, but people may need two doses of thevaccine for it to be fully effective, so not everyone will be able to receive it right away.
In a press release this week, Pfizer saidthe company is on track to seek regulatory review "as early as October 2020" and that if the vaccine gets approved, they could supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
If the vaccine is approved, it's unclear who would get itfirst. Modernaand the FDA did not respond to questions about the process, but Gruber said that will be a decision that is left up to government agencies. He said he suspects that frontline workers, essential workers, older individuals and those at greater risk will be seriously considered for earlier access to vaccines.
To complicate the goal of herd immunity further, a poll fromThe Associated Press-NORC Center for Public Affairs Research found that 20% of respondents would refuse to take a vaccine if oneis approved, and another 31% were unsure.
Anti-vaccination sentiment is part of what pushed Lunaria to volunteer for trials.
"In this time when so many people are so crazy about science and vaccines, people like me need to walk our talk," she said.
In the meantime, the Internet continues to be fertile ground for dark warnings, misinformation and ungrounded conspiracy theories about the coronavirus and plans for a vaccine potentially driving down the numbers of those who would get a shot.
A Pew Research Center survey in late June asked people if they had heard the theory that the COVID-19 outbreak itself was planned by people in power. Seventy-one percent of U.S. adults said yes. A third of those respondents said it was "definitely" or "probably" true.
In a common version of this discredited theory, the pandemic is a global plan hatched by elites such as Microsoft billionaire Bill Gates to implant tracking chips along with vaccinations that would be activated by 5G cellular technology. Its been widely shared on platforms like Facebook.
The postings gained enough media attention to prompt Gates to deny any such sinister plot.
"I've never been involved in any sort of microchip-type thing, he said in a call with reporters. "It's almost hard to deny this stuff because it's so stupid or strange."
Another theory puts Dr. Fauci at the heart of the conspiracy, falsely claiming he was in a 2015 photo at a Chinese lab in Wuhan along with President Barack Obama. The photo was taken at a lab in Maryland.
Michigan United for Liberty, the group that hosted an April 30 Lansing protest against Gov. Gretchen Whitmers stay-at-home order, is raising the alarm as well about a COVID-19 vaccine.
Michigan United for Liberty organizer Alex Larner, identified on the groups website as secretary of the Eaton County Tea Party, has used his personal Facebook page to share unfounded conspiracy videos on the fake science behind the fear mongering of the WuFlu.
The end goal of the WuFlu pandemic is mandatory vaccines, Larner wrote May 9.
Warren resident Diane Barnes supports the aims of Michigan for Vaccine Choice, which lobbies for the right of parents to opt out of vaccines for their children.
Its one strand of a broader anti-vaccine movement that may have paved the way for a 2014 outbreak of whooping cough at a Traverse City charter school that spawned more than 150 suspected cases. It was tied to parents wary of vaccinations, as 17 percent of kindergartners had parents who signed waivers exempting their children from immunizations.
In 2014, Michigan had the fourth highest rate of unvaccinated kindergartners in the nation. State law at that time required parents to immunize school-age kids against communicable diseases such as measles, whooping cough, mumps and tetanus unless they received a waiver that allowed them to opt out for medical, religious or philosophical reasons.
To reduce the number of waivers, MDHHS in 2015 mandated that parents who want to opt out for non-medical reasons must sit down with a local health worker for an educational session on vaccine-preventable diseases before obtaining a waiver. In the first year after that rule was enacted, MDHHS reported the number of statewide waivers dropped by 35 percent as child vaccination rates began to rise.
Barnes told Bridge shes not persuaded that COVID-19 is part of any global vaccine plot orchestrated by Gates and Fauci.
Im not buying into that, she said.
But she said she has no intention of getting a COVID-19 vaccine.
Johnson, of Grand Rapids, said her reluctance goes beyond her fear that the medical community may be tempted to cut corners in the quest to approve a vaccine.
She said shes troubled by the political environment, magnified by her view of President Trumps handling of the pandemic.
I just dont trust him, she said. I think hes a liar.
Sitting at a table at a Grand Rapids park with a friend, Gerard Mayweather had more stoic reasons for opting out of a COVID-19 vaccine. Its not because, as an African American, he believes the government is somehow conspiring against him.
I just think getting the virus is inevitable, he said.
Do I wear a mask? Do I wash my hands? Yes, he said.
But the way this goes, I think its inevitable I will get it. I had cancer twice and Im all right. I refuse to be a prisoner to this.
