The approved vaccines are highly effective against preventing severe COVID-19 disease, hospitalization, and death. However, the rapid rollout of the vaccines left some unanswered questions about the long-term effects of COVID-19 vaccination.
One study, published today in The BMJ, examined the association between COVID-19 vaccines, COVID-19 infection, and risk of immune meditated neurological events. The investigators looked for evidence of 4 neurological conditions: Bells palsy (facial weakness), encephalomyelitis (inflammation of the brain and spinal cord), Guillain-Barr syndrome (a nerve condition), and transverse myelitis (inflammation of the spinal cord).
The study included 8330497 people who received at least 1 dose of a COVID-19 vaccine by January 13, 2022, ascertained from primary care records in the UK and Spain. At the time, there were 5 COVID-19 vaccines authorized by the European Medicines Agency, including the Pfizer-BioNTech and Moderna mRNA vaccines, the Oxford-AstraZeneca and Janssen viral vector vaccines, and the recombinant spike protein nanoparticle vaccine Novavax.
Overall, 4376535 people received AstraZeneca, 3588318 received Pfizer-BioNTech, 244913 received Moderna, and 120731 received Janssen. The study also included a total of 735870 unvaccinated people infected with COVID-19, and 14330080 people from the general population, studied retroactively to estimate historical background pre-pandemic.
The patient primary care records came from The Clinical Practice Research Datalink (CPRD) AURUM in the UK, and the Information System for Research in Primary Care (SIDIAP) database in Spain.
Post-vaccination rates of Bells palsy, encephalomyelitis and Guillain-Barr syndrome were consistent with rates established from the background study cohort. Transverse myelitis events were < 5 in all vaccinated groups and could not be analyzed.
Notably, rates of Bells palsy, encephalomyelitis and Guillain-Barr syndrome were all higher than anticipated after COVID-19 infection. The study was not causational, so the investigators did not speculate on why this was. Broken down by individual risk the increased likelihood of developing a neurological condition after COVID-19 infection was small, but even a small risk can burden the healthcare system.
The results from such large studies show that neurological conditions are no more common among vaccinated people than among unvaccinated people (without prior COVID-19 infection). We may never be able to tell exactly what caused an individual to develop a neurological condition, but COVID-19 vaccination is a highly unlikely reason for most, the investigators concluded.
According to a Reuters report published earlier today, the United States, European Union, India, and South Africa have reached an agreement on a waiver with respect to patents for COVID-19 vaccines (see Andrea Shalal and Emma Farge, "U.S., EU, India, S.Africa reach compromise on COVID vaccine IP waiver text," Reuters). Progress on the compromise appears to have been made during a recent meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on March 9-10. In a statement issued by the World Trade Organization (WTO) on March 10, the WTO noted that:
Some of the members participating since December 2021 in the high-level talks the European Union, India, South Africa and the United States expressed cautious optimism about a possible outcome and asked for patience from the rest of the membership. These members said that the small-group discussions continue to take place in good faith, with the objective of finding a landing zone that delivers on the common purpose of ensuring equitable access to vaccines, therapeutics, and diagnostics.
As we reported last year, India and South Africa proposed in the fall of 2020 that the WTO TRIPS Council recommend "a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19" to the General Council of the WTO. The two countries also recommended that "[t]he waiver should continue until widespread vaccination is in place globally." As we reported last May, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines."
Although the details of the waiver proposal are still being finalized, and the text of the compromise proposal has not been released, the Biotechnology Innovation Organization (BIO) and U.S. Chamber of Commerce both issued statements this afternoon on the reported compromise. A statement released by Chief Policy Officer John Murphy noted that:
While we have seen the reported outlines of an alleged compromise on the TRIPS waiver, we still need to see and review the full text before rendering a final judgment. However, the irrational fixation on weakening IP is simply a distraction from the real challenge of overcoming global vaccine hesitancy, removing actual trade barriers, and helping countries to strengthen their healthcare infrastructure so that we can get more shots in arms. In 2021 alone, companies produced more than 11 billion doses of COVID vaccines, enough to give two shots to every adult on the planet.
Strong, predictable intellectual property protections are what allowed biopharma companies to produce COVID vaccines and therapeutics in record time. It laid the foundation for cross-border partnerships, global scientific collaboration, and an unprecedented manufacturing scale-up that ensured vaccines could reach every corner of the world. Dismantling the foundation of innovationa strong and predictable IP systemwill only make us less prepared to respond to the next pandemic and weaken our ability to develop new classes of medicines the world needs.
In a statement released by the U.S. Chamber of Commerce Global Innovation Policy Center, Senior Vice President Patrick Kilbride, the Chamber contended that:
This proposal is fundamentally misguided and should be rejected. It ignores that the overwhelming problem is not vaccine production, it is last-mile delivery, and it will erode the ability of innovative companies to develop the cure for the next pandemic or global health threat.
Business is delivering on the promise to manufacture safe and effective COVID-19 vaccines for the whole world. Vaccine production is estimated to reach over 20 billion doses this year, enough for everyone. As of March, over 65% of global population has received at least one dose, and this number is growing every day. Some patients remain hard to reach. Governments and international organizations should avoid political distractions and more quickly achieve comprehensive global vaccination against COVID-19, by focusing on real, practical ongoing issues with last-mile distribution.
Intellectual property waiver proposals distract from the real issues preventing more shots in arms such as logistical hurdles, supply chain bottlenecks, and vaccine hesitancy. Worse yet, dismantling IP rights threatens the licensing arrangements that are enabling rapid global production and technology transfer. Any WTO action undermining IP will harm multiple U.S. industries, who are global leaders in their fields, and who depend on IP protections. Any agreement of this kind would bargain away US competitiveness.
For additional information regarding this topic, please see:
"Sen. Tillis Writes to U.S. Trade Representative (Again) Regarding TRIPS Waiver," December 12, 2021 "U.S. Trade Representative Responds to Letters from Senators Regarding TRIPS Waiver," November 14, 2021 "U.S. Chamber of Commerce Urges Administration to 'Double Down' on Global Vaccine Distribution," November 3, 2021 "Is This the WTO Waiver End Game?" July 25, 2021 "BIO Declaration on Global Access to COVID-19 Vaccines and Treatments and Role of IP," June 24, 2021 "GOP Legislators Write in Opposition to Proposed TRIPS Waiver," May 16, 2021 "Population of Patents at Risk from Proposed WTO Patent Waiver," May 12, 2021 "Sen. Daines Urges Biden Administration to Withdraw Support for COVID-19 IP Waiver," May 12, 2021 "Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver," May 10, 2021 "If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?" May 9, 2021 "The Road to Hell Is Paved with What Everybody Knows," May 6, 2021 "BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver," May 6, 2021 "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines," May 5, 2021 "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)," April 26, 2021 "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal," April 21, 2021 "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021 "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021 "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021 "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021
18 March 2022
Proskauer Rose LLP
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Tennessee Governor Bill Lee has signed into law a bill that expandsprotections for employees who are subject to employer COVID-19vaccine mandates.
The new law supplements existing state law that prohibits privateemployers and other entities from compelling or otherwise taking"adverse action" against a person to compel the person toprovide proof of vaccination if the person objects to receiving aCOVID-19 vaccine "for any reason." The law defines"adverse action" to include denying employment ordischarging, threatening or otherwise discriminating against anemployee "in any manner that affects the employee'semployment, including compensation, terms, conditions, locations,rights, immunities, promotions, or privileges." The existinglaw gives applicants and employees a right to seek injunctiverelief and to recover compensatory damages and reasonableattorneys' fees for violations.
Effective March 11, 2022, the new Tennessee lawprovides that "[a]n employer that requires a person to provideproof of vaccination or requires an individual receive the COVID-19vaccine must grant the person an exemption to the policy if: (1)the person provides a valid reason for a medical exemptionsupported by a statement that has been signed and dated by alicensed healthcare provider; or (2) the person states that theperson has a religious belief which prevents the person fromcomplying with the policy." For an exemption based onreligious belief, the law prohibits the employer from requiring anindividual to provide further proof beyond their initial statementin order to be granted an exemption. Notably, unlike federal law,there is nothing in this new law that enables employers to denysuch exemption requests because the exemption would cause an unduehardship for the employer or otherwise create a direct threat tothe employee or others in the workplace.
Employers also are required to provide a response to requestsfor an exemption within two (2) business days, and must not deny arequest without a written explanation explaining why the requestwas denied. The law further prohibits employers from discharging,threatening to discharge, or reducing the compensation of a personwho requests and is granted an exemption.
Violations of the new law are punishable by a civil penalty of$10,000.
Tennessee Expands Employee Protections Relating toCOVID-19 Vaccine Mandates
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Japans Prime Minister Fumio Kishida has announced plans to fully lift coronavirus restrictions on March 21 as new infections driven by the highly contagious omicron variant slow
By MARI YAMAGUCHI Associated Press
March 16, 2022, 11:44 AM
3 min read
TOKYO -- Japans Prime Minister Fumio Kishida on Wednesday announced plans to fully lift coronavirus restrictions on March 21 as new infections driven by the highly contagious omicron variant slow.
The COVID-19 restrictions currently in place in 18 prefectures, including the Tokyo area, will end on Monday as planned, Kishida said at a news conference on Wednesday, as his government seeks to cautiously expand consumer activity to help the badly hurt economy get back on track.
This will be a transitional period so that we can return to our normal daily lives as much as possible by taking maximum precautions, Kishida said.
It will be the first time Japan has been free of virus restrictions since early January. The plan will be formally adopted after an experts panel endorses it on Thursday.
Daily caseloads have steadily declined in Japan in recent weeks after surging to new highs exceeding 100,000 in early February. New cases have fallen by about half.
The lifting of restrictions will allow more domestic travel, as well as parties and larger gatherings for people with vaccination records and negative virus tests, Kishida said.
But Japan is not opening its border to foreign tourists yet.
Kishida on Wednesday did not mention further easing of Japans border controls. His government has eased border restrictions by increasing the limit on daily new arrivals to 7,000 in order to allow in foreign scholars, students, business people and interns after criticisms from inside and outside Japan that locking them out is exclusionist and unscientific.
While omicron causes mild symptoms in most people and the fatality rate remains low, the latest wave is the deadliest one so far in Japan because the total number of patients were many times higher than in earlier waves. Still, deaths in Japan total about 26,000 since the pandemic began two years ago, significantly lower than many other countries.
Most victims were elderly patients whose underlying illnesses rapidly worsened after contracting the virus, experts said.
Kishida has faced criticism that he delayed booster shots until all municipalities were ready, allowing the virus to quickly spread in the country.
His government has since opened mass inoculation centers to speed up the booster program. About 72% of people aged 65 or older have received their third jabs, but overall booster vaccines have reached only one-third of the population.
Experts urge caution after the lifting of restrictions due to the possibility of a resurgence of infections. A subvariant of omicron is gradually replacing the primary strain around the country.
In some areas, hospital bed occupancy rates still exceed 50%, and oral antiviral pills are not reaching as many people as expected. Although Kishida's government has pledged to secure millions of doses of the two imported oral pills, they are not widely used. One is rather large and hard to swallow, and another cannot be combined with many other drugs.
The ongoing COVID-19 restrictions are largely limited to eateries, where shorter service hours are requested. The general public is also asked to work from home and avoid parties and large events, as well as to wear masks while in public places and follow other basic anti-virus measures.
WASHINGTON At least nine House Democrats have announced in the last five days that they tested positive for the coronavirus, with more than half of those cases emerging after lawmakers attended a party retreat last week in Philadelphia.
It is unclear what drove the wave of cases or where the representatives had been infected. But members of the House spent hours on the floor without masks for votes that stretched late into the night last Wednesday before Democrats boarded buses to travel to their gathering.
The infections offered a jarring reminder that, even as top officials seek to pivot away from strict restrictions and encourage Americans to learn to live with the coronavirus, the pandemic rages on. The White House announced on Tuesday that Doug Emhoff, the husband of Vice President Kamala Harris, had tested positive for the virus.
The uptick was all the more striking given that Democrats, including members of Congress and President Bidens team, have generally been far more supportive of strict precautions against the virus, while Republicans have been vocal opponents of mask mandates and other measures, arguing that they are excessive and an encroachment on personal freedom.
Still, even as reports of the infections circulated in Washington and cases continued to spike globally, there was little indication that officials at the White House or in Congress would reimpose a series of precautions that they have just begun to roll back. It reflects decisions across the country, where leaders are dropping pandemic-era restrictions and mandates.
The White House announced on Tuesday that public tours would resume in April, after being suspended at the start of the pandemic. At the other end of Pennsylvania Avenue, senior lawmakers and officials on Capitol Hill are discussing plans to reopen the building to tourists, according to aides briefed on the discussions, after House Democrats moved this month to lift a mask mandate in their chamber.
Fully vaccinated lawmakers will not be required to wear a mask on Wednesday, as members of the House and the Senate gather in a joint session for a virtual address by President Volodymyr Zelensky of Ukraine. (Unvaccinated lawmakers will have to wear a mask, though it is unclear how rigorously that will be enforced.)
Representatives Jared Golden of Maine, Joe Neguse of Colorado and Andy Kim of New Jersey announced within about an hour of one another on Tuesday morning that they had tested positive for the coronavirus. Mr. Neguse attended the retreat along with four others who reported testing positive in recent days: Representatives Madeleine Dean of Pennsylvania, Zoe Lofgren of California, Kim Schrier of Washington and Rosa DeLauro of Connecticut.
Two other House Democrats, Representatives Gerald E. Connolly of Virginia and Peter Welch of Vermont, also said they tested positive on Friday and Monday, respectively. They were not present at the retreat, according to a person in attendance who spoke on the condition of anonymity to discuss attendance at the private gathering.
Representatives, their staff members and their families were required to take P.C.R. or rapid antigen tests before the event, and attendees were required to take rapid tests in their hotel rooms on Thursday and Friday.
Mr. Biden delivered an in-person speech at the retreat on Friday. The White House press secretary, Jen Psaki, said on Tuesday that because all representatives at the retreat were vaccinated, a change in the presidents behavior would not be warranted according to C.D.C. guidelines. She reiterated that Mr. Biden received a negative test result on Sunday.
Many members of the House were also together on the floor late Wednesday night to pass a major spending bill before they departed for Philadelphia, though it is unclear which members were physically present because remote voting was allowed. Most of the Democrats who tested positive emphasized that they were vaccinated, and said it was a reminder that the pandemic was not yet over.
I caught COVID on 2yr anniversary of pandemic, Mr. Kim wrote on Twitter. Yes I feel miserable. Woke up in middle of night with fever, but Im not scared like I would have been year or 2 ago. That doesnt mean Im not worried.
The outbreak among House Democrats comes amid rising concerns about a surge in coronavirus cases in parts of Europe and Asia, as well as warnings from public health experts that the United States could see a summer or fall surge.
The Democrats were joined on Tuesday by a Republican colleague, Representative Fred Upton of Michigan, who said on Twitter that he was experiencing mild symptoms after a routine test came back positive.
Annie Karni contributed reporting.
Good evening. Im Karen Kaplan, and its Tuesday, March 15. Heres the latest on whats happening with the coronavirus in California and beyond.
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Everyone is eager for the pandemic to be over. But what about the nations public health emergency?
They sound like interchangeable terms, but theyre not the same thing.
The COVID-19 pandemic is a global outbreak of a novel infectious disease. In the United States, the public health emergency is a declaration by the government that our well-being is endangered by COVID-19 and the coronavirus that causes it.
Alex Azar, who served as secretary of the Department of Health and Human Services under President Trump, declared the public health emergency way back on Jan. 31, 2020, and made it retroactive to Jan. 27. That was mere weeks after the Chinese government informed the World Health Organization about a mysterious outbreak of pneumonia in Wuhan. The disease did not yet have a name, and the coronavirus was not yet known as SARS-CoV-2. It took about six more weeks for the WHO to label the outbreak a pandemic.
By declaring a public health emergency, Azar established a legal foundation for an array of government actions designed to respond to and ideally contain the virus. The initial declaration expired after 90 days and has been renewed continuously ever since. It will be up for renewal again April 15.
The public health emergency has one thing going for it that the pandemic doesnt: It can be ended with the stroke of a pen.
Lots of Americans say theyre ready to see that happen. Among them are 76 Republicans in Congress who sent a letter to President Biden and Xavier Becerra, Azars successor, demanding that they begin the process of unwinding the public health emergency as soon as possible so our country can get back to normal.
Thats not likely to happen as soon as the lawmakers want. Even if it did, life wouldnt exactly go back to the way things were in 2019, because the coronavirus is still among us.
But some things would go away, my colleague Melissa Healy reports.
For instance, the Biden administration would lose the clear legal authority to invoke the Defense Production Act to make companies produce pandemic necessities such as personal protective equipment. And the Centers for Disease Control and Prevention would give up its power to require that face masks be worn on airplanes, buses and other forms of public transit.
You might not lose much sleep over those things. You might even be happy to see them go.
But what about Paxlovid? Thats the new pill from Pfizer that can reduce the risk of severe COVID-19 by as much as 89%. The Food and Drug Administration issued an emergency use authorization for the pill in December, clearing the way for doctors to prescribe it to newly diagnosed patients.
Heres the thing about emergency use authorizations: Theyre only good while a public health emergency is in effect. When the emergency is over, the only drugs and medical devices that will still be available will be those that cleared the FDAs usual and lengthy approval process.
Two COVID-19 vaccines are FDA-approved, but Comirnaty (the one made by Pfizer and BioNTech) is approved only for people 16 and older, and SpikeVax (the one made by Moderna) is approved only for adults. As things now stand, if the public health emergency ended tomorrow, no one under 16 would be able to get vaccinated.
Likewise, the only COVID-19 drug with full FDA approval so far is Veklury (aka remdesivir).
A grocery store offers N95 respirator masks provided by the U.S. Department of Health and Human Services.
(Rogelio V. Solis / Associated Press)
The public health emergency also makes COVID-19 vaccines, tests and treatments free to the public, because the government either picks up the tab or makes health insurance companies do so. Once the emergency is over, you may find yourself paying for things youre used to getting for free.
Telemedicine took off during the pandemic, and when health insurance companies balked at paying for it, the government ordered them to cover virtual visits as if they had taken place in person. That was possible because of the public health emergency.
And while the declaration is in place, its much more difficult for states to remove people from their Medicaid rolls. If the health emergency is not renewed next month, nearly 13 million Americans are likely to lose their health coverage, according to an analysis from the Robert Wood Johnson Foundation and the Urban Institute.
People have been wishing for back to normal, but you should be careful what you wish for, said Georgetown Universitys Lawrence Gostin, an expert in public health law. Thisll be a whole new world.
California cases and deaths as of 6:04 p.m. on March 15, 2022:
Track Californias coronavirus spread and vaccination efforts including the latest numbers and how they break down with our graphics.
In California, the number of new coronavirus cases reported each day has plunged 70% over the past two weeks, and daily COVID-19 deaths have fallen nearly 50% during the same period. Hopefully both trends will continue even as we ease up on mask mandates, vaccination requirements and other precautions.
But if they dont, how will we know?
Los Angeles County health officials have a plan. Theyve devised a list of nine things to watch for an early indication of trouble, should it arise. They include:
New coronavirus cases: Unless all L.A. County residents are periodically screened for coronavirus infections, we cant know exactly how many cases there are. But if a new outbreak gets underway, a signal should appear in the case data.
COVID-19 hospitalizations: This tells us whether a new outbreak is causing serious illnesses. If it does, the urgency to respond will be greater.
Emergency room visits: Officials want to know what percentage of ER visits involve COVID-19 patients. As long as its below 5% over the course of a week, their level of concern is low; if it rises above 10%, their level of concern will be high.
Viral variants: A portion of the coronavirus specimens collected from patients is selected for genetic sequencing. If a variant of concern arrives on the scene and is sequenced, health officials will be able to spot it. The countys plan says if 5% or more of the specimens sent for sequencing turn out to be variants of concern (as designated by the WHO), it could portend a new surge. And if that figure exceeds 10%, its particularly worrisome.
Low-income areas: Health officials arent just interested in countywide metrics; they also want to keep tabs on the neighborhoods that have been hit hardest throughout the pandemic. Ideally, there will be fewer than 100 cases per 100,000 residents of low-income areas. If there are more than 200 cases per 100,000 residents, that would trigger high concern.
The four remaining indicators are specific settings where health officials are on the lookout for new outbreaks.
Schools: This includes elementary and secondary schools throughout the county. The goal is to see no more than three coronavirus outbreaks per week. If there are 10 are more, the level of concern would be high.
Skilled nursing facilities: The target for these places is no more than 10 outbreaks per week. If the number exceeds 20, health officials would be highly concerned.
Homeless shelters: The targets for these are the same as for skilled nursing facilities.
Work sites: Authorities would like to see fewer than 100 outbreaks each week. If there are more than 300, theyd be in highly concerned territory.
So how are we doing? According to the most recent data available, L.A. County is doing quite well, my colleagues Rong-Gong Lin II and Luke Money report.
As of Sunday, the only category that isnt in the realm of low concern is schools. K-12 schools reported four outbreaks in the most recent week, just enough to generate a moderate level of concern. But looking on the bright side, those four outbreaks represent an improvement over the previous week, when there were seven.
A first-grader gets her nose swabbed for a coronavirus test at Telfair Elementary School in Pacoima.
(Myung J. Chun / Los Angeles Times)
Most of the other indicators are safely in the low-concern category. But a couple are somewhat close to the boundary with moderate concern. Last week, 4.3% of emergency room visits were coronavirus-related; as mentioned, the goal is to stay below 5%. Also, officials counted eight outbreaks in homeless shelters; the goal is not to exceed 10.
Having one indicator in the moderate range is something to keep an eye on. If two indicators enter that territory, well conduct an in-depth review of contributing factors and consider changes to community-prevention strategies, said Barbara Ferrer, L.A. Countys director of public health.
In a worst-case scenario, such as the arrival of a new variant thats impervious to the immunity weve received through vaccines and past infections, universal mask mandates and other rules could be reinstated.
See the latest on Californias vaccination progress with our tracker.
At schools across California, students arrived Monday with the freedom to do something that hasnt been possible all year: go without a face mask the entire day.
Not every school exercised its option to let students go mask-free. Los Angeles Unified, the largest district in the state, still has its mask mandate in place under a deal with the teachers union. And students in San Diego Unified have to keep their masks on until they return from spring break on April 4.
But for those who had a choice, the milestone day brought feelings of joy, relief, caution and uncertainty.
Giselle Frisby, a senior at Redondo Union High School in Redondo Beach, was somewhat distressed to find that only one of the four teachers she had Monday chose to wear a mask. Yes, they were optional, but state and county health officials strongly recommend that people continue to wear them. Giselle wore a surgical mask to protect herself from her unvaccinated classmates and for the sake of her dad, who has a medical condition.
Her classmate Jake Hatakeyama hates wearing a mask, especially while playing sports. He went mostly mask-free except for when he was near one of his teachers, who has a newborn at home.
More freedoms may be coming soon. Members of the Los Angeles City Council have taken the first steps toward lifting COVID-19 vaccine verification requirements for restaurants, salons, gyms, movie theaters and other businesses that are now required to confirm patrons vaccination status before serving them indoors.
Council members unanimously voted to draft an ordinance that would make vaccine verification voluntary instead of mandatory. The change would apply to operators of major outdoor events as well. Once the new ordinance is written, it will need to be approved in a future council meeting before it goes into effect.
Rules are being relaxed in other states as well. The governor of Hawaii announced plans to drop the nations last statewide indoor mask mandate by March 26.
And in April, the CDC will stop requiring everyone to wear a mask while taking any form of public transit or while in a transportation hub, such as an airport or a subway station. That broad mandate will be replaced with more targeted policies, officials said.
The U.S. is looking more and more like Europe, where countries have been dropping pandemic restrictions for weeks. France joined them Monday by doing away with the need for masks in most settings and allowing people to dine out, ride trains, go to theaters and attend sporting events without having to flash a vaccine pass.
Frances move came even though the number of new infections there is once again on the rise. The country is averaging more than 60,000 new cases per day over the past week, up from about 50,000 a week earlier. The United Kingdom and other European nations are also seeing their cases rise.
That has some health experts fearing the same will happen in the U.S. this spring.
As we have seen throughout the pandemic, the U.S. [has] followed Europe by several weeks in our waves of cases. That may happen again here, Andy Slavitt, a former senior adviser to President Bidens pandemic response team, wrote on Twitter.
Slavitt attributed the rise in European cases to BA.2, a sublineage of Omicron that spreads about 30% faster than the still-dominant BA.1. According to the CDCs most recent estimate, BA.2 accounts for about 23% of coronavirus specimens in the U.S., up from about 14% the week before and just 7% the week before that.
Dr. Eric Topol, director of the Scripps Research Translational Institute in La Jolla, said waning immunity and a relaxation of safety rules also factored into Europes rising caseload. If so, thats even more ominous for the U.S.
Speaking of waning immunity, Pfizer is expected to ask the FDA to authorize a second COVID-19 booster dose for senior citizens, according to a person familiar with the matter. Among all age groups, seniors have experienced the highest COVID-19 death rates by far, especially people who are 75 and older. If the FDA authorizes another booster, the CDC would have to sign off as well.
On a related note, L.A. County has launched the test to treat COVID-19 program introduced by President Biden during his recent State of the Union address. People who test positive for a coronavirus infection at a participating CVS health clinic can get one of two types of anti-COVID pills either Paxlovid or a less-effective drug made by Merck & Co. called molnupiravir for free. Both pills work best when taken as soon after possible after an infection. More information about the program is available online or by calling (833) 540-0473.
On to Asia, where the pandemic picture looks very different than it does here. The latest update from the WHO says the Western Pacific region saw coronavirus cases jump 46% week-to-week, even as infections dropped 5% for the planet as a whole. In addition, while global COVID-19 deaths fell 8%, deaths in the Western Pacific rose 29%.
China, the largest country in the region, said it recorded 3,507 new cases on Tuesday. Thats more than double the 1,337 new cases it tallied on Monday. Altogether, the country has announced more than 10,000 cases so far in March, making it Chinas biggest outbreak by far since the initial days of the pandemic.
Nearby, South Korea experienced its deadliest day of the pandemic on Tuesday, with 293 casualties. An additional 1,196 COVID-19 patients are in serious or critical condition. Health officials there expect the situation to get worse.
COVID-19 isnt done with Americans, either. In just the past few days, both former President Obama and Doug Emhoff, the husband of Vice President Kamala Harris, tested positive for coronavirus infections.
Todays question comes from readers who want to know: What is Deltacron, and do I need to worry about it?
Deltacron is the nickname of a new version of the coronavirus thats a mishmash of the Delta and Omicron variants.
Although these strains were responsible for the last two surges, officials say the hybrid is nothing to worry about right now.
Only a handful of Deltacron infections have been documented nationwide, Dr. Erica Pan, the state epidemiologist, told the California Medical Assn. At least one of those cases was in the Golden State, she said.
As of Friday, the combo variant had not been detected in L.A. County, Ferrer said. In fact, she added, its too scarce to get a handle on whether its resistant to existing vaccines and treatments.
California health officials arent the only ones taking Deltacron in stride. Neither the CDC nor the WHO has seen fit to designate it a variant of concern, or even a variant of interest. To qualify for one of those labels, Deltacron would need to be causing clusters of infections in multiple countries. It would also need to have genetic mutations that make it behave (or are suspected to make it behave) in a way thats distinct from its predecessors.
We want to hear from you. Email us your coronavirus questions, and well do our best to answer them. Wondering if your questions already been answered? Check out our archive here.
(Robert Gauthier / Los Angeles Times)
Id like to give a shoutout to the enterprising folks in the photo above.
Socorro Juarez is the one on the left, dressed as a syringe. Rosa Cardona is on the right, dressed as a coronavirus. My colleague Robert Gauthier spotted them a few weeks ago in San Juan Capistrano.
At least once a week, the pair don their costumes in an effort to persuade fellow Latinos to get vaccinated against COVID-19. According to the Times tracker, 46% of Latinos in California arent fully vaccinated, including the 38% who have yet to receive their first shot.
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Practice social distancing using these tips, and wear a mask or two.
Watch for symptoms such as fever, cough, shortness of breath, chills, shaking with chills, muscle pain, headache, sore throat and loss of taste or smell. Heres what to look for and when.
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WASHINGTON Over the past 10 months, as tens of millions of children and teenagers received the Pfizer-BioNTech vaccine, the companies main rival, Moderna, sat on the sidelines, its shot limited to adults.
But Moderna may now be poised for a comeback at a critical juncture in the nations vaccination campaign. The company is expected to send federal officials initial data this week on how well its coronavirus vaccine works for the nations youngest children.
About 18 million children under the age of 5 are the only Americans not yet eligible for vaccination. And while uptake for older children has been slow, many parents are still anxiously awaiting the chance to protect their babies, toddlers and preschoolers.
Moderna is going head-to-head with Pfizer-BioNTech for the opportunity to vaccinate this group, hoping it has found what some scientists are calling the Goldilocks dose: strong enough to offer lasting protection, but not so strong that it causes widespread worrisome side effects, such as high fevers.
Moderna has opted for a regimen of two doses at a quarter the strength of its adult dose for children under 6. Pfizer is expected to seek authorization next month for a three-shot regimen for children under 5, with doses one-tenth as strong as those for people aged 12 and up.
Moderna is also expected to release data soon from its clinical trial on the next age group up: children aged 6 to 11.
Dr. Yvonne Maldonado, a Stanford professor of pediatric infectious diseases and a lead investigator at the Stanford site of Pfizers pediatric vaccine trials, said new data from both Moderna and BioNTech in the coming weeks will offer critical insight into the effectiveness of their pediatric shots. She said researchers are watching carefully to see if Modernas stronger doses result in more robust immune responses than Pfizers shots have elicited in young children.
A series of new studies raising questions about how long Pfizers lower doses protect elementary-school-age children has piqued interest among federal scientists and vaccine experts in Modernas choices.
Dr. Ofer Levy, a pediatric expert at Harvard Medical School and a member of the Food and Drug Administrations independent vaccine advisory committee, said he thought Pfizer might have selected too low a dose for 5- to 11-year-olds in the understandable priority to maximize safety.
To date, Pfizer has been the only player in vaccinating younger Americans, winning authorization to vaccinate 12- to 15-year-olds last May, followed by 5- to 11-year-olds in October. Its authorization for adults also covers 16- and 17-year-olds.
Moderna sought authorization to vaccinate teenagers last June, but the F.D.A. delayed considering the request because of concerns about the risk of myocarditis, a condition involving inflammation of the heart that has been tied to both the Moderna and the Pfizer shots.
More than 22 million people in the United States under 18 are now fully vaccinated with the Pfizer vaccine, but uptake has been leveling off. Only roughly one in four children ages 5 to 11 are fully vaccinated, for example, even though shots have been offered to that group for more than four months.
But there is still a demand to protect the youngest children as more of the country unmasks, more parents return to workplaces and the summer travel season approaches.
Compared with adults, there is no question that in children the benefit of an effective vaccine is less, because fewer get really sick, said Dr. Eric Rubin, an infectious disease expert at the Harvard T.H. Chan School of Public Health and a member of an advisory panel to the Food and Drug Administration.
But it will benefit some individuals, he said. It will save some lives. According to the Centers for Disease Control and Prevention, 336 children in the United States under the age of 5 have died of Covid since the start of the pandemic.
Hopes that the youngest children would soon be covered surged last month after regulators pressed Pfizer-BioNTech to submit preliminary results from its three-dose trial. The F.D.A. wanted to get the vaccination campaign underway with two doses while awaiting final results on three.
March 16, 2022, 4:45 p.m. ET
But that effort collapsed when new data from Pfizer that encompassed more of the Omicron surge showed convincingly that two doses failed to protect adequately against symptomatic infection.
Now, more detailed results from Pfizers and Modernas trials are materializing at roughly the same time. And while neither company knows yet whether its vaccines will prove effective enough for the youngest age group, but both say their research shows they are safe.
We have not seen anything untoward right now, so we feel confident in the safety profile, Dr. Paul Burton, Modernas chief medical officer, said in an interview.
Amy Rose, Pfizers spokeswoman, has said that after careful research, Pfizer-BioNTech chose the safest and most tolerable dose for young children. The companies have said they are hopeful that a three-shot regimen will provide strong protection for children under the age of 5. Pfizer is testing a 10-microgram dose for 5- to 11-year-olds, a third of the adult and teenage dosing; and 3 micrograms for children under 5.
Moderna is proposing substantially higher dosing than Pfizer in all three pediatric age groups: 100 micrograms, the full adult dose, for those ages 12 to 17; 50 micrograms in children 6 to 11, and 25 micrograms in those under 6. Regulators are considered likely to review the firms data for all three age groups simultaneously.
We really stand behind those doses, Dr. Burton said. Although federal officials say both Pfizer and Modernas vaccines wane in potency over time, some studies of adults have suggested that Modernas protection holds up longer. I think it comes down to dose, Dr. Burton said.
He said initial results showed a 50-microgram Moderna dose prompted a robust immune response in children 6 to 11. While the overall number of infections was small, researchers hope that trial will help reveal how well the vaccine prevents illness, not just how high it boosts antibody levels.
Dr. Philip Krause, who recently retired as a senior vaccine regulator at the F.D.A., said the agency spent significant time last year worrying about the safety of Modernas vaccine for those under 18, with some studies showing a higher risk of myocarditis from the companys shot than from Pfizers.
The question is always: What is the dose that gives rise to an immune response that we think is likely to be protective? he said. You couldnt actually test to figure out the rate of myocarditis since its rare, but you could ask, What are we sacrificing in immune response by lowering the dose, and do we think thats important?
Partly because of concerns about myocarditis, the C.D.C. recently encouraged some people 12 or older, particularly boys and men between 12 and 39, to wait eight weeks between their first and second Pfizer or Moderna shots. Studies have shown that teenage boys and young men are most at risk of developing the side effect.
Dr. Burton said that overall the research had proved reassuring, including recent British data that showed myocarditis was very rare and typically mild in both Pfizer and Moderna recipients.
But Dr. Walid F. Gellad, a drug safety expert at the University of Pittsburgh, said it remained unclear whether Modernas higher dosing might elevate the risk of myocarditis in young children. The companys pediatric studies are most likely much too small to identify the risk of the side effect, he and other experts said.
Modernas new push also comes after several studies raised questions about the protection that two doses of Pfizer-BioNTechs vaccine provide for children 5 to 11. Researchers in New York States health department recently found that protection against infection from two doses faded significantly within weeks.
C.D.C. researchers separately found that during the Omicron wave, the effectiveness of two doses of the Pfizer shot against moderate forms of the disease in children ages 5 to 11 dropped significantly.
The studies have kindled a debate among vaccine experts about whether a stronger dose would have been better or whether those children need third doses. Booster shots are now authorized for everyone 12 and up. Pfizer expects results from its study of a three-dose regimen for the younger children next month.
Dr. Gellad said it was possible the Pfizer dose for 5- to 11-year-olds may have been too weak, but that scientists could not yet be certain. He said he expected regulators would be especially careful in considering higher doses for young children given the comparatively low risks of them catching Covid now and getting severely ill.
Amid all the questions, one thing is clear: The back and forth over which vaccine will be better for young children could discourage uptake.
Alison M. Buttenheim, a behavioral health expert at the University of Pennsylvania, said those considering vaccination found comfort in certainty. Otherwise, thats just going to pave the way to say, Im going to hold off, she said. A lot of people are uncomfortable with evolving science.
COVID-19 cases and deaths have been falling across the U.S. for several weeks as the omicron wave recedes. But the Centers for Disease Control and Prevention says a new subvariant of omicron is beginning to spread BA.2, also known as "stealth omicron."
The CDC said Tuesday that the BA.2 subvariant now represents 23% of newly-reported COVID-19 cases across the country. The subvariant is also spreading rapidly in China where officials are re-instituting lockdown measures and in Europe, where some countries are seeing a second omicron wave.
So, what is "stealth omicron," and how is it different? And will it lead to another wave of cases in the U.S.?
What is stealth omicron?
According to the American Medical Association, BA.2 is a subvariant of the omicron variant of COVID-19. Scientists have referred to it as "stealth" omicron because it has "genetic mutations that could make it harder to distinguish from the delta variant using PCR tests as compared to the original version of omicron."
Why are scientists concerned?
Omicron itself is already more contagious than previous variant strains of COVID-19. However, the American Medical Association says that BA.2 is 1.5 times more infectious than the original omicron strain.
Does stealth omicron cause more severe disease?
There's conflicting research. According to ABC News, a study conducted by Japanese scientists studied the effects of BA.2 on hamsters and found the subvariant caused more severe infections than omicron. However, two separate studies from Denmark and South Africa showed that BA.2 presented similar risks for hospitalizations compared to the original omicron strain.
Do vaccines work against stealth omicron?
All indications indicate that COVID-19 vaccines are still effective against BA.2, particularly against severe disease and death, according to Vox.
Will there be another surge in cases?
Scientists are holding out hope that the U.S. will be spared from another omicron surge. They hope that the millions of Americans who had an omicron infection in recent months will have some protection against BA.2 and that immunity levels will only rise as more people seek out vaccines and boosters.
But other countries are seeing a resurgence in COVID-19, particularly in China, which is seeing its biggest outbreak since the virus first emerged in Wuhan. CNBC reports that COVID-19 cases are also on the rise in France, Switzerland, Italy and the Netherlands.
But even as "stealth omicron" is becoming more prevalent in the U.S., case rates, hospitalizations and deaths are still falling.
"Although BA.2 does seem to be growing as a proportion of sub-lineages in the United States, it's not nearly as quickly as we've seen in some other countries. The doubling time in the United States actually seems to be slowing down," Dr. Deborah Dowell, the CDC's chief medical officer for the agency's COVID-19 response, said Tuesday, according to CBS News.
PENNSYLVANIA (WHTM) As COVID-19 cases decline following the omicron spike and Pennsylvania health officials move toward a new phase of the pandemic, it feels like the coronavirus is getting close to shifting from pandemic to endemic.
Experts say there are certain signs that could indicate when the change may be near.
Endemic diseases occur regularly in a population and follow established patterns. One common example of an endemic disease is the flu.
I think were in the transition from this being pandemic to endemic. I dont think were there yet. What I do expect is most of the population gets at least some form of immunity, and probably by the summer this will become a very different disease, said Dr. John Goldman, Infectious Disease Specialist at UPMC.
So what signs will indicate the shift to endemicity?
Goldman said next winter, if COVID-19 hospitalizations look like a typical flu season rather than a previous COVID-19 peak, the disease may be moving into endemicity.
With positivity rates and case incidences down, Penn Medicine Lancaster General Health Chief of Infectious Diseases Dr. Joseph Kontra said, I think the trends that were seeing are certainly pointing in that (endemic) direction.
COVID-19, so far, has been fairly unpredictable, a trait of a pandemic disease rather than an endemic one. New variants like delta and omicron caused unexpected spikes in coronavirus cases, hospitalizations, and deaths. Kontra said this may be changing, though.
Theres no indication at this point in any of the testing thats being done that a new variant has popped up yet, so if that continues to be the case, then I think well be in pretty good shape for the summer, Kontra said as of March 9.
Some places may reach the endemic stage sooner than others, Goldman said.
Id be looking at the U.S. to see if its nationally endemic or pandemic. I would also be looking locally because there are going to be states that, for example, have less vaccinations, which are going to go into the endemic stage more slowly than states like Pennsylvania that have higher rates of vaccination, explained Goldman.
Goldman said the shift to endemicity may come depending on what happens next winter. Kontra and Dr. Raghav Tirupathi, medical director of infection prevention at WellSpan Chambersburg and WellSpan Waynesboro Hospitals, said it may come even earlier if the COVID-19 situation stays consistent into the summer.
There is a possibility that COVID-19 infection could become endemic with steady rates of infection by summer, Tirupathi said in an email, but that again also comes with a certain mortality rate from this infection.
Tirupathi noted that just because a disease is endemic doesnt mean that its not also deadly, explaining malaria is endemic in several parts of the world but has killed about 600,000 people in 2020 and tuberculosis is endemic in several parts of the world and has killed about 1.5 million people in 2020.
Even a typical flu season causes tens of thousands of deaths and hundreds of thousands of hospitalizations, Goldman noted.
The term endemic has been used in a lax fashion. Endemic state does not mean stable state as it can still cause periodic surges and disruptions to daily life. The last thing we want is the public letting down guard against this nasty disease. Masking in high-risk situations, vaccination, early testing and treatment should continue to be cornerstones of prevention, Tirupathi said via email.
As for who officially designates COVID-19 as endemic, the Associated Press reported in January that most wealthy countries will probably make that decision themselves based on their individual situations, but they may watch for the WHO to switch COVID-19 away from its highest level of alert of global health emergency.
