Editors note: So youve gotten your coronavirus vaccine, waited the two weeks for your immune system to respond to the shot and are now fully vaccinated. Does this mean you can make your way through the world like the old days without fear of spreading the virus? Deborah Fuller is a microbiologist at the University of Washington working on coronavirus vaccines. She explains what the science shows about transmission post-vaccination and whether new variants could change this equation.
The short answer is no. You can still get infected after youve been vaccinated. But your chances of getting seriously ill are almost zero.
Many people think vaccines work like a shield, blocking a virus from infecting cells altogether. But in most cases, a person who gets vaccinated is protected from disease, not necessarily infection.
Every persons immune system is a little different, so when a vaccine is 95% effective, that just means 95% of people who receive the vaccine wont get sick. These people could be completely protected from infection, or they could be getting infected but remain asymptomatic because their immune system eliminates the virus very quickly. The remaining 5% of vaccinated people can become infected and get sick, but are extremely unlikely to be hospitalized.
Vaccination doesnt 100% prevent you from getting infected, but in all cases it gives your immune system a huge leg up on the coronavirus. Whatever your outcome whether complete protection from infection or some level of disease you will be better off after encountering the virus than if you hadnt been vaccinated.
Transmission happens when enough viral particles from an infected person get into the body of an uninfected person. In theory, anyone infected with the coronavirus could potentially transmit it. But a vaccine will reduce the chance of this happening.
In general, if vaccination doesnt completely prevent infection, it will significantly reduce the amount of virus coming out of your nose and mouth a process called shedding and shorten the time that you shed the virus. This is a big deal. A person who sheds less virus is less likely to transmit it to someone else.
This seems to be the case with coronavirus vaccines. In a recent preprint study which has yet to be peer reviewed, Israeli researchers tested 2,897 vaccinated people for signs of coronavirus infection. Most had no detectable virus, but people who were infected had one-quarter the amount of virus in their bodies as unvaccinated people tested at similar times post-infection.
Less coronavirus virus means less chance of spreading it, and if the amount of virus in your body is low enough, the probability of transmitting it may reach almost zero. However, researchers dont yet know where that cutoff is for the coronavirus, and since the vaccines dont provide 100% protection from infection, the Centers for Disease Control and Prevention recommends that people continue to wear masks and social distance even after theyve been vaccinated.
New variants of coronavirus have emerged in recent months, and recent studies show that vaccines are less effective against certain ones, like the B1351 variant first identified in South Africa.
Every time SARS-CoV-2 replicates, it gets new mutations. In recent months, researchers have found new variants that are more infective meaning a person needs to breathe in less virus to become infected and other variants that are more transmissible - meaning they increase the amount of virus a person sheds. And researchers have also found at least one new variant that seems to be better at evading the immune system, according to early data.
So how does this relate to vaccines and transmission?
For the South Africa variant, vaccines still provide greater than 85% protection from getting severely ill with COVID19. But when you count mild and moderate cases, they provide, at best, only about 50%-60% protection. That means at least 40% of vaccinated people will still have a strong enough infection and enough virus in their body to cause at least moderate disease.
If vaccinated people have more virus in their bodies and it takes less of that virus to infect another person, there will be higher probability a vaccinated person could transmit these new strains of the coronavirus.
If all goes well, vaccines will very soon reduce the rate of severe disease and death worldwide. To be sure, any vaccine that reduces disease severity is also, at the population level, reducing the amount of virus being shed overall. But because of the emergence of new variants, vaccinated people still have the potential to shed and spread the coronavirus to other people, vaccinated or otherwise. This means it will likely take much longer for vaccines to reduce transmission and for populations to reach herd immunity than if these new variants had never emerged. Exactly how long that will take is a balance between how effective vaccines are against emerging strains and how transmissible and infectious these new strains are.
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Vaccines have brought the United States tantalizingly close to crushing the coronavirus within its borders. After months of hiccups, some 1.4 million people are now being vaccinated every day, and many more shots are coming through the pipeline. The Food and Drug Administration has just authorized a third vaccine a single-dose shot made by Johnson & Johnson while Pfizer and Moderna are promising to greatly expand the supply of their shots, to roughly 100 million total doses per month, by early spring.
If those vaccines make their way into arms quickly, the nation could be on its way to a relatively pleasant summer and something approaching normal by autumn. Imagine schools running at full capacity in September and families gathering for Thanksgiving.
But turning that if into a when will require clearing additional hurdles so that everyone who needs to be vaccinated gets vaccinated. This is especially true for racial minorities, who are being disproportionately missed by the vaccination effort.
Theres plenty of disagreement among experts as to why America is still having problems with vaccine uptake. Some officials have suggested that the main cause is that too many people are hesitant to get the vaccine. Others point the finger at overcautious public health officials who they say have undersold the promise of the vaccines. Still others point to long lines at clinics as proof that far more people want the vaccine than can actually get it.
There is probably some truth to all of these hypotheses, and the underlying problems are not new. Vaccine hesitancy had been growing steadily in America long before the current pandemic, so much so that in 2019 the World Health Organization ranked it as one of the leading global health threats. At the same time, poor health care access and other logistical constraints, such as a lack of public transportation and limited internet access, have long impeded public health efforts in low-income communities.
To maximize the number of Americans getting vaccinations, policymakers need to tackle each of these crises with greater urgency than they have so far.
As supply increases, health officials should mount ambitious vaccination campaigns modeled on ones that have worked to curb diseases in other countries. That will mean not relying solely on web portals for scheduling vaccine appointments. It will mean going block by block and door to door, through high-risk communities especially. It will mean setting up employee vaccination sites at schools, grocery stores, transit hubs and meatpacking plants, and community clinics at houses of worship, with local leaders promoting and running them.
The easier you can make it for people to get vaccinated, the more likely your program will be to succeed, said Dr. Walter Orenstein, a former director of the national immunization program at the Centers for Disease Control and Prevention. Its really that simple.
Outreach efforts cost money. But theyre far less expensive than allowing the pandemic to fester. Congress has appropriated some money to help states with vaccine rollout. It should offer more, and states should put as much of those resources as possible toward vaccination efforts that meet people where they are.
Health officials should also recognize that vaccine hesitancy has many root causes deliberate disinformation campaigns, mistrust of medical authorities in marginalized communities, ill-considered messaging by health officials. The best way to counter that is with campaigns that are locally led, that clearly outline the benefits of vaccination and that frame getting the shot as not just a personal choice but a collective responsibility.
Doctors and scientists can help those pro-vaccine messages stick by minding their own public communications. Its crucial to be transparent about what vaccines will and wont do for society overselling now will only sow more mistrust later.
That said, underselling is its own problem. Its true that these vaccines will not immediately restore the world to total normalcy. But they will eventually allow people to hug their loved ones, to return to their offices and to be protected from dying from or becoming seriously ill with Covid-19. Health officials should be clear about that.
Policymakers at the highest levels of government should press social media companies and e-commerce sites to curb the most aggressive purveyors of vaccine disinformation.
To not only quell this pandemic but to try to prevent the next one, America will need to improve its health system and its public health apparatus, both of which have significant holes. The problem with a lot of the response is that it was predicated on the idea that we have a good system in place for doing adult immunizations across the country, said Dr. Peter Hotez, a vaccine expert at Baylor College of Medicine. The fact is, we really dont.
In the end, lawmakers and the people who vote them into office will have to address the much broader problems that this pandemic has exposed.
BANGKOK Thailand started its first vaccinations Sunday with 200 public health officials receiving the Sinovac vaccine from China.
Health Minister and Deputy Prime Minister Anutin Charnvirakul was given the first shot at a hospital near Bangkok, followed by the deputy health minister and other senior officials.
Prime Minister Prayuth Chan-ocha, who attended the vaccination ceremony, said the public should have confidence in the safety and effectiveness of the vaccine, as it has been approved by authorities in Thailand and other countries.
Prayuth did not receive the vaccine on Sunday because he is older than Sinovacs recommended age, which is 18-59. Prayuth is 66.
Thailand received the first 200,000 doses of the Sinovac vaccine on Wednesday. They are part of the governments plan that has so far secured 2 million doses from Sinovac and 61 million doses from AstraZeneca.
Thailand has had more than 25,000 confirmed cases and 83 deaths from COVID-19.
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THE VIRUS OUTBREAK:
J&Js one-dose shot cleared, giving U.S. a 3rd COVID-19 vaccine
Plunging demand for COVID-19 tests may leave US exposed
Biden hails House passage of $1.9 trillion virus bill, now to Senate
New York state mandates dance zones, distancing when weddings resume
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Follow all of APs pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak
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HERES WHAT ELSE IS HAPPENING:
WASHINGTON The U.S. now has a third vaccine to prevent COVID-19.
The Food and Drug Administration on Saturday cleared a Johnson & Johnson shot that works with just one dose instead of two.
Health experts have anxiously awaited a one-and-done option to help speed vaccinations. The virus has already killed more than 510,000 people in the U.S. and is mutating in increasingly worrisome ways.
The FDA said J&Js vaccine offers strong protection against what matters most: serious illness, hospitalizations and death. One dose was 85% protective against the most severe COVID-19 illness, in a massive study that spanned three continents.
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LONDON Church bells rang out and a World War II-era plane flew over the funeral service of Captain Tom Moore, in honor of the veteran who raised millions for Britains health workers by walking laps in his backyard.
Captain Tom, as he became known, died Feb. 2 at age 100 after testing positive for COVID-19. Just eight members of the veterans immediate family attended Saturdays private funeral service, but soldiers carried his coffin and formed a ceremonial guard.
Daddy, you always told us Best foot forward and true to your word, thats what you did last year, Moores daughter Lucy Teixeira said at the service.
Moore, who served in India, Burma and Sumatra during World War II, set out to raise a modest 1,000 pounds for Britains NHS by walking 100 laps of his backyard by his 100th birthday last year. But donations poured in from across Britain and beyond as his quest went viral.
His trademark phrase Please remember, tomorrow will be a good day inspired the nation at a time of crisis. He was knighted by Queen Elizabeth II in July at Windsor Castle.
A version of the song Smile singer Michael Bubl recorded for the funeral was played. So was My Way by Frank Sinatra, as Moore requested.
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MILAN The Lombardy region where Milan is located is heading toward a partial lockdown on Monday. Mayor Giuseppe Sala said in a video message he was disturbed by scenes of people gathering in public places, often with their masks down.
Italy has failed to flatten the curve on the fall resurgence, with numbers of new infections and deaths remaining stubbornly high amid new variants creating new outbreaks. The Italian Health Ministry reported 18,916 new infections and 280 deaths on Saturday.
The regions of Lombardy, Piedmont and Marche will go into partial lockdown on Monday, meaning no table service at bars and restaurants. Police vans blocked entrance to Milans trendy Navigli neighborhood Saturday evening after the mayor announced increased patrols to prevent gatherings during a spring-like weekend.
Basilicata and Molise will be designated red zones on Monday, which means upper grades will have remote learning and non-essential stores are closed. A 10 p.m. curfew remains in effect throughout the country.
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ALBANY, N.Y. New Yorks new coronavirus-era dance rules arent exactly Footloose strict, but dont plan on cutting loose and kicking off the Sunday shoes with just anybody.
The state says when wedding receptions resume next month, guests will be allowed to hit the dance floor only with members of their immediate party, household or family seated at the same table.
Gov. Andrew Cuomo previously announced weddings can begin again on March 15. Venues will be restricted to 50% of capacity, up to 150 guests, and all must be tested for coronavirus beforehand.
Dancers must wear face masks and stay within their own dancing areas or zones.
Happy couples can still take a twirl for a ceremonial first dance, and other couples can join in, but they must all stay 6 feet apart.
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BISMARCK, N.D. Nearly 10% of residents in North Dakota have completed both doses of the COVID-19 vaccine.
The North Dakota Department of Health data indicates nearly 70,000 people in the state, or 9.5% of the population, have received the full two-dose series. More than 126,000, or 17.3%, have received the first dose.
North Dakota reported three COVID-19-related deaths on Saturday, bringing the states confirmed death toll to 1,445. Another 71 cases were confirmed, for a total of 99,780 overall.
Meanwhile, the North Dakota Department of Commerce announced $20 million in grants to help the states hotels, motels and lodging businesses that lost revenue due to the pandemic.
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INDIANAPOLIS Nearly 900 new cases of the coronavirus and 27 more deaths have been reported in Indiana.
The Indiana Department of Health says the 897 newly diagnosed cases bring the states confirmed total to 660,942 since the start of the pandemic.
The state has registered 12,125 deaths, while another 431 probable deaths have been reported based on clinical diagnoses in patients with no positive test on record.
More than 981,000 Indiana residents have received a first dose of the COVID-19 vaccine and 552,241 are fully vaccinated.
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JUNEAU, Alaska The federal government has approved Alaskas plan to give the states fishing industry almost $50 million in pandemic relief.
Commercial applicants will be required to provide evidence that the coronavirus pandemic caused them to lose at least 35% of revenue in 2020. Applications will be accepted from March until May.
Alaska Department of Fish and Game Deputy Commissioner Rachel Baker says the final plan excludes commercial permit holders who fish in Alaska but live in other states that received coronavirus relief. Payments could begin as early as June.
CoastAlaska reported Friday the decision came after two major revisions to the plan and more than 200 public comments from every industry sector.
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CARIBOU, Maine Republican Sen. Susan Collins of Maine wants the Biden administration to reconsider U.S.-Canada border restrictions that were imposed a year ago because of the pandemic.
Her letter came less than a week after Department of Homeland Security announced the U.S., Mexico and Canada had jointly agreed to maintain land border restrictions until March 21.
Collins wrote in a letter to DHS Secretary Alejandro Mayorkas that an equitable solution is needed for border communities that recognizes lower risk levels.
Only Canadian citizens, Americans with dual citizenship and family members and partners can cross for nonessential purposes.
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SEATTLE People looking for a unique outdoor dining option during the pandemic can now make a run to the home of the Seattle Seahawks.
A dining series called Field to Table kicked off this month at Lumen Field. It features four-course meals from local chefs, plus a view of the NFL stadium normally reserved for players and coaches.
Diners eat their meals under an open-sided tent on the field, near the north end zone.
Event producer Sam Minkoff says the series original dates quickly sold out, but additional reservations will be available soon.
A portion of the proceeds go to the nonprofit Big Table, which helps struggling restaurant and hospitality workers. Seattle area eateries recently resumed reduced-capacity indoor seating after being restricted to takeout or limited outdoor seating.
The Religion of the City: Cars, Mass Transit and Coronavirus
Or
Religion is a uniquely human reality. As are cities. As we emerge from our burrows of sequestration, the silent cities and places of worship will become human again, versus the present sad memory of what they once were.
We will recover from another human reality, the pandemic and when we do we will be forced to address some questions. Before this century, the automobile was once seen as the way Americans could create a new reality: a huge middle class that could control its life by using the freedom that cars gave them to go where they wanted, when they wanted, and to live where they wanted. Before this latest change of sequestration, that vision of what cars meant to our culture was changing especially in cities.
Mass transit, the lifeblood of many cities, is seen as a universal good as the inevitable direction all humanity should follow. The climate crisis meant that the more people traveled together the less carbon was created. So mass transit was an answer, until using it infected millions of people with the Coronavirus virus.
But mass transit is just one way to fight the climate crisis. You could also recreate cities to Live Work Learn Play in one community, with hundreds of these places knitted together within existing communities. For a generation, city planner Jeff Speck advocated the creation of Walkable Cities as the future of our urban life if we were to reduce our carbon footprint and assert aesthetic control of our environment from the profit-driven creation of segregated zoning districts and residential towers in our cities.
In that full-on prescription of a movement away from living in suburbia and in skyscrapers, John Massengale wrote a terrific book Street Design: The Secret to Great Cities and Towns in 2014 with Victor Dover (it even had a foreword by HRH The Prince of Wales!). A fully formed future was offered, in both common sense and aesthetic experience. Cars are seen fully subordinated in our cities, with fully realized examples in Europe projected to be our future. But the world has hit a change time, and these visions may change too.
The common denominator of the last 40 years of urban rethinking in light of the climate crisis and the failures of centralized, functionally segregated cities are obvious. In the last century, cities were often gutted to allow unlimited car movement and access. These inhuman, dangerous and plain ugly brutalizations of our cities undeniably showed that cars are The Great Satan. But ideology often collides with cultural realities. With religious fervor, New Urbanism has been visioned with cars as necessary evils, and or cities being changed to limit their impact.
But all religions run up against the world they exist in. After World War 2, American religion itself was seen as essential, necessary, fully integrated into our culture, with over 75% of the population being engaged in it. Now, that interest is being halved. I think that a post-pandemic world will create yet more change for our cities and religion.
Human needs do not change, but human values do. The extreme devotion to cars and religion of the mid-XX century has reversed, but I think the full-stop on so much of our XXI century lives caused by the pandemic has caused rethinking by many. Anecdotally, places of worship, which were largely prohibited from traditional functioning for a year, are changing, not dying. The buildings built to be central in our lives, religious sacred spaces are seen as being less essential, not only because fewer people are devoted to traditional worship, but are shown that gathering in a building is not essential after sequestration prevented it, but churches survived. I think that the relationship between our cities, cars, and mass transit will be changed by the pandemic, too and by the way, cars are evolving. Cars may not be consigned to the ash bin of urban planning as visioned before the pandemic.
In this century, cities are making great efforts to limit car use within their borders, but the total miles driven on American roads was increasing before the pandemic (and has year on year) after a dip caused by the Great Recession, even though whole neighborhoods are becoming pedestrian-only.
But Manhattan, the epicenter of both Coronavirus and mass transit, has seen car use spike and mass transit use crater as people need to travel, but are terrified to pack subways and busses, and some places are just too far to walk. Many cities like New Haven and San Francisco have taken dramatic steps to discourage car use including extensive traffic calming efforts in a time where the alternative to newly risky mass transit use is, in fact, cars, and that means that more traditional internal combustion engines will sit and spew carbon into the air.
Independent of this changing time, the electric car revolution is in full throttle. Manufacturers like Volvo are dedicating themselves to be fully electric in their engines, reducing emissions. The objections to carbon production by cars will become mute in the next generation, so the objections to the rampage of cars through our cities will become more aesthetic and lifestyle-focused.
Those living during sequestration in cities are universally depressed over all the things they cannot do shows, museums, dining. Some have simply left to go out to places that are less dense suburbia, a place where cars still rule communities and culture. The once-proud beacons of religious faith, churches, and other places of worship, are being abandoned too. But while the buildings are empty, the congregations are still connected, some are even growing, connected through the internet. The conventional wisdom is that Zoom and live streaming are a temporary fix to a pandemics brutal isolation, but these electronic alternatives may actually revive worship that had seen a full-on erosion of in-building presence for decades.
Could it be that despite traffic calming that same reliance on virtual living will crimp the need for and economic viability of mass transit? If so, will cars, especially electric cars, become newly viable within our cities? If so, designers will, once again, envision ways to integrate quiet, emission-less cars into an urban fabric that has spent two generations focused on the elimination of the automobile as the denominator of so much of urban life.
Outcomes often happen that we cannot know, let alone follow our carefully crafted motivations.
We invite you to check out ArchDaily's coverage related to Coronavirus, read our tips and articles on Productivity When Working from Home, and learn about technical recommendations for Healthy Design in your future projects. Also, remember to review the latest advice and information on COVID-19 from the World Health Organization (WHO) website.
URBANA With the health of Champaign County improving daily, the judiciary is ready to welcome jurors back.
Three big courtrooms. Three masked judges. No waiting.
After postponing jury trials in December, January and February, Champaign County Presiding Judge Randy Rosenbaum said they will begin again Monday.
Whether actual or not, there was a perception of a backlog of cases, particularly people in jail who wanted a trial, he said. Normally, one judge at a time handles felony trials. To help with the backlog, I have assigned three judges to handle felony trials for the next two weeks.
The trial moratorium was declared in mid-December to prepare for a predicted post-holiday surge in COVID-19 cases. The idea was to keep people who did not absolutely need to be in the courthouse out of it.
With the number of infections decreasing and the ranks of the vaccinated increasing, Rosenbaum rallied the troops to start the wheels of justice turning fully.
After a lot of tinkering with the details, the process should be fully operational Monday.
Rosenbaum and Judge Roger Webber normally hear all the felony jury trials. Judge Jason Bohm, who handles a civil caseload, is on backup to hear any cases that Rosenbaum and Webber cant handle.
While there is a possibility of three trials going on at once, the selection of jurors to hear those trials, assuming they materialize, will be staggered to keep the numbers manageable. Defendants frequently accept negotiated plea agreements once they know trials are set to begin. And sometimes, key witnesses cant be found and trials either have to be continued or cases dismissed.
Those summoned for jury duty may watch their orientation video virtually at home, and are encouraged to do so.
Those who dont have the ability to do that can watch it in the spacious jury assembly room on Monday.
Rosenbaum said summonses were sent to 120 people, 20 more than usual. He and his colleagues are hoping that most of those summoned will show up to insure an ample pool.
Were moving the lawyers further away from the jurors, we are spreading out the jurors farther, and are putting more Plexiglas between lawyers and jurors, Rosenbaum said of some of the courtroom modifications.
Of the 11 courtrooms in the 19-year-old courthouse, three are considerably larger than the other eight. They were designed for high-volume dockets like traffic and arraignment.
Turns out they fit the bill for being able to spread out and are now earmarked for trials only during the two weeks jurors are in the house.
To prepare those courtrooms, county maintenance workers removed the first two rows of benches on one side of the gallery behind the bar that separates the public from the court and jury.
That was done to be able to spread the 12 jurors and two alternates out so they will be at least 6 feet apart. The schematic involves putting five jurors in the jury box, one in front of the jury box, four in front of the bar, and four just behind the bar in chairs where the uncomfortable 90-degree benches normally are.
As with the jury trials done during the summer, jurors will go to two separate jury rooms during their breaks. When it comes time to deliberate, they will be put in one of the smaller courtrooms so they can spread out.
The logistics of just how many spectators may be in the courtroom is still being calculated, Rosenbaum said.
Jury trials typically dont hold the same allure for the public as a blockbuster movie premiere, but the occasional high-profile murder case can mean lots of supporters for both victims and defendants.
Trials must be open to the public so Rosenbaum said there may be a trial where courthouse staffers will have to reconfigure seats to safely accommodate all who would like to be present.
For Immediate Release: February 27, 2021
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States, said Acting FDA Commissioner Janet Woodcock, M.D. The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agencys rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.
The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccines known and potential benefits outweigh its known and potential risks, supporting the companys request for the vaccines use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.
The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive spike protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
After a thorough analysis of the data, the FDAs scientists and physicians have determined that the vaccine meets the FDAs expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. With todays authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDAs unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.
FDA Evaluation of Available Safety Data
The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.
As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.
It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.
FDA Evaluation of Available Effectiveness Data
The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.
Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.
There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe/critical in the vaccine group versus 34 cases in the placebo group.
At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.
The EUA Process
On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.
The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.
The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.
Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA describing its commitment to monitor the safety of Janssen COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Janssen COVID-19 Vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.
The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).
The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
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The Philippines has received its first batch of COVID-19 vaccine
By JIM GOMEZ Associated Press
February 28, 2021, 9:23 AM
3 min read
MANILA, Philippines -- The Philippines received its first batch of COVID-19 vaccine Sunday, among the last in Southeast Asia to secure the critical doses despite having the second-highest number of coronavirus infections and deaths in the hard-hit region.
A Chinese military transport aircraft carrying 600,000 doses of vaccine donated by China arrived in an air base in the capital in a late-afternoon event beamed live on state-run TV. President Rodrigo Duterte and top Cabinet officials welcomed the delivery of the vaccine from China-based Sinovac Biotech Ltd. in a televised ceremony that underscored their relief after weeks of delays, officials said.
That plane is carrying hope that we can finally return to our lives and light for our very dark journey, presidential spokesperson Harry Roque said.
Vaccinations initially of health workers and top officials led by the health secretary were scheduled to start in six Metropolitan Manila hospitals Monday.
Aside from the donated vaccine from Sinovac Biotech, the government has separately ordered 25 million doses from the China-based company. An initial 525,600 doses of COVID-19 vaccine from AstraZeneca were also scheduled to arrive Monday, Roque said.
The initial deliveries are a small fraction of at least 148 million doses the government has been negotiating to secure from Western and Asian companies to vaccinate about 70 million Filipinos for free in a massive campaign largely funded with foreign and domestic loans. The bulk of the vaccine shipments are expected to arrive later this year.
Resty Padilla, a spokesperson for a government panel dealing with the pandemic, said the vaccine could be a game-changer in a debilitating health crisis that has infected more than 576,000 people in the Philippines and killed at least 12,318 others. Lockdowns and quarantine restrictions have also set back Manilas economy in one of the worst recessions in the region and sparked unemployment and hunger.
Although we are still a long way from herd immunity, the arrival of the initial supply of vaccine provides hope that our road to normalcy has finally begun, Padilla told The Associated Press.
Dutertes administration has come under criticism for lagging behind most other Southeast Asian countries in securing the vaccines, including much smaller and poorer ones like Cambodia, Myanmar and Laos.
The tough-talking Duterte has said wealthy Western countries, especially where the vaccine originated, have cornered massive doses for their citizens, leaving poorer nations scrambling to get the rest. In a sign of desperation, the president said last December that he would proceed to abrogate a key security pact with the United States that allows large numbers of American troops to conduct war exercises in the Philippines if Washington could not provide at least 20 million doses of COVID-19 vaccine for his country.
No vaccine, no stay here, Duterte said then.
The Chinese vaccine delivery was delayed due to the absence of an emergency-use authorization from Manilas Food and Drug Administration. Sinovac got the authorization last Monday. Western pharmaceutical companies also wanted the Philippine government to guarantee that it would take responsibility for lawsuits and demands for indemnity arising from possible adverse side effects from the vaccine, officials said.
Duterte signed a law last week giving pharmaceutical companies immunity from such liabilities for the emergency use by the public of their vaccine.
Associated Press writer Edna Tarigan in Jakarta, Indonesia, contributed to this report.
7,200 appointments for COVID-19 vaccine are to be canceled within the next 24 hours KUTV 2News
About 600 military veterans went in waves to get shots in arms throughout the day Saturday as theDepartment of Veterans Affairs Pacific Island Healthcare System held the first in a series of mass COVID-19 vaccinations.
The veterans had to be at least 60 years old, be in a high risk health category or be an essential worker to make an appointment at the Keehi Lagoon Memorial event.
That gave many of them their first opportunity to get the vaccine since the state is only offering vaccines to first-responders and others who are at least 70 according to the general priority system. They will get their second doses in a follow-up event.
Army veteran Francis Ouye, 73, said he hopes the vaccinations will allow life to return to normal soon so he can visit Southeast Asia.
I feel very fortunate that the VA provides this service to us, he said after receiving his shot. Im looking forward to everyone getting vaccinated so that I can travel.
The VA inoculated 600 veterans at the Keehi Lagoon Memorial on Saturday during its first mass vaccination event in Hawaii.
Kevin Knodell/Civil Beat
Winter storms on the mainland disrupted the supply chain of vaccines to the island last week, explained VA Pacific Island Healthcare System Assistant Director Katherine Kalama.
As our supply increases, we need to increase our throughput. Bottom line is that the VA goal is to put as many vaccines in veterans arms as we can, Kalama said. Well be doing many more of these events in the future.
Kalama said they hope to hold the next event in Kapolei and are trying to coordinate with the National Guard to use one of their facilities there.
The VA Pacific Island Healthcare System is unique in that its responsible for veterans throughout Hawaii as well as the Pacific Island territories of American Samoa, Guam and the Northern Marianas. But it has no dedicated facilities of its own, instead relying on partnerships with military and civilian hospitals and clinics across the region.
Amy Rohlfs, a VA spokeswoman, said that has posed additional challenges for vaccination efforts in terms of finding locations that could accommodate large scale efforts.
On Oahu, the VA operates out of Tripler Army Medical Center, which can be hard to access for some veterans. The hospital recently got funding for badly needed new parking facilities from Congress. However the VA has expanded its clinic hours for those able to make it there for vaccinations.
Rohlfs also said it was difficult to schedule appointments for those with jobs, but holding a mass event simplified the process.This is like stop-and-go easy, she said of the mass vaccination.
However, it wasnt a drop-in vaccination event every veteran had to register in advance due to limited supplies. Anyone interested has to be a registered patient with the VA Pacific Island Healthcare System.
Thats really important that theres coordination with these guys, said Dr. Chaz Baritz, the Pacific Island Systems top pharmacist. He oversees the storage and transportation of the vaccines to facilities and to patients across the region.
At the event Saturday they kept the vaccines in powered refrigerated bags that can keep the vaccine cold for up to five days.
Were using them today to transport, said Baritz. These vials are good 12 hours out of the refrigerator at room temperature and (up to) puncture so for todays event we dont really need to keep them chilled, but we just like to have that practice.
The bags have played a much larger role in transporting the vaccine to veterans on the neighbor islands.
We are transporting the vaccine to our most rural areas. Were going to each one of our islands to ensure that all of our veterans have an opportunity, said Kalama. Were going to continue to do that until everybodys vaccinated.
The VA Pacific Island System has also continued vaccinations in the other Pacific Island territories and is working with the U.S. Department of Health and Human Services to administer vaccinations not just to veterans but to civilians in American Samoa.
While scarce supplies has meant a fierce competition over who gets to be vaccinated first, the next challenge will be persuading vaccine skeptics to get inoculated.
Ouye hopes everybody will get the vaccine when offered, either for themselves or for the next person.
To date, the VA Pacific Island Healthcare System said it has vaccinated1,070 employees and more than 6,280 veterans across the region.
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