WILMINGTON, N.C.--(BUSINESS WIRE)--The PPD clinical research business of Thermo Fisher Scientific and Moderna, whose pioneering mRNA vaccine for COVID has been administered to hundreds of millions globally, were named Clinical Research Team of the Year during the 2021 Citeline Awards.
As Modernas clinical research organization partner, the PPD team, now part of Thermo Fisher, supported Modernas mRNA-1273-P301 vaccine trials, including its pivotal Phase III COVE study. The study enrolled more than 30,000 participants, ages 18 and older, across 99 U.S. sites in 12 weeks in the summer/fall of 2020. The Citeline Award for Clinical Research Team of the Year recognizes this massive joint undertaking.
The PPD and Moderna team worked tirelessly to deliver the COVE trial, working long days side by side in partnership, said Melanie Ivarsson, Ph.D., chief development officer at Moderna. We would also like to acknowledge and thank all the clinical trial investigators and staff, and all the participants who took part in the COVE trial.
The Moderna and PPD teams worked closely with the Biomedical Advanced Research and Development Authority and the National Institutes of Health, including National Institute of Allergy and Infectious Diseases COVID-19 Prevention Network, to conduct the Phase III COVE study under Operation Warp Speed.
Moderna's COVID-19 vaccine was available under emergency use authorization in the U.S. beginning in December 2020, and in January 2022, the U.S. Food and Drug Administration approved the biologics license application for the vaccine, marketed as Spikevax, to prevent COVID-19 in individuals 18 years of age and older.
This recognition honors our strong collaboration with Moderna and reinforces our shared commitment to develop life-saving vaccines and therapies, said David M. Johnston, Ph.D., senior vice president and president, clinical research, Thermo Fisher Scientific. Were excited to continue supporting Moderna on next-generation, multivalent and variant-specific vaccines in Phase I-III studies through our infrastructure, experience and complementary services.
The Citeline Awards recognize accomplishments across the biopharmaceutical industry and honor the highest achievers. Citeline presented the award during its annual ceremony, held in Boston.
The PPD clinical research team has supported Modernas research initiatives since 2016 across its expanding portfolio, including vaccines, oncology, rare diseases and autoimmune conditions. In February 2022, Thermo Fisher announced a 15-year strategic collaboration agreement with Moderna for dedicated large-scale manufacturing in the U.S. of Spikevax and other investigational mRNA medicines in its pipeline. This expanded agreement includes dedicated capacity for a range of aseptic fill-finish services, including lyophilized and liquid filling, and inspection, labeling and final packaging services.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
A Covid-19 vaccine developed by the French pharmaceutical company Valneva has been given regulatory approval by the Medicines and Healthcare products Regulatory Agency, bringing the total number of jabs approved for use in the UK to six.
As the Covid pandemic swept the world, scientists began developing vaccines against it, with the Pfizer/BioNTech jab being the first in the UK to be authorised for emergency use by the MHRA in 2020. Since then the MHRA has approved the Moderna, Oxford/AstraZeneca, Janssen and Novavax vaccines, although, according to NHS England, Janssen and Novavax are not currently available.
The UKs independent medicines regulator was the first in the world to approve the Valneva product, the MHRA said. Unlike the other approved Covid jabs, the Valneva vaccine is an inactivated whole-virus vaccine, which means the live virus was grown in a laboratory, rendered unable to infect cells, then administered to people to trigger an immune response.
The MHRA said this approach was already being used for flu and polio vaccines and experts have previously suggested that Covid jabs based on the whole virus may result in a broader immune response than those that involve only the spike protein, and may work better against new variants.
Results released by Valneva in October suggested the vaccine could be as effective as the Oxford jab. In addition, it is stable when stored in a standard refrigerator, which could make it easier to distribute than some other Covid jabs.
Prof Sir Munir Pirmohamed, the chair of the independent Commission on Human Medicines, said the commission and its Covid-19 expert working group had carefully considered the evidence and advised that the benefit-risk balance was positive. The vaccine is approved for use in people aged 18 to 50 years, with the first and second doses to be taken at least 28 days apart.
Prof Adam Finn, a member of the Joint Committee on Vaccination and Immunisation and the chief investigator on the Valneva clinical development programme, said that while the jab had been approved it was unlikely to be available in the UK soon, as the government had cancelled its contract to buy the vaccine in September.
However, he said the jab could prove more acceptable than others to some people. The people who could theoretically benefit from it now are unvaccinated 18- to 50-year-olds who want immunisation but are hesitant about currently available vaccines, he said, adding that the Novavax jab could also appeal to this group.
However, there was another hurdle. In the UK, no one has yet been offered any choice as to which vaccine they receive, said Finn, a professor of paediatrics at Bristol University.
The number of deaths involving coronavirus registered each week in England and Wales have continued to increase, although levels remain well below those reached during previous Covid waves.
Omicron XE, which was first detected in the United Kingdom, has been found in the U.S. and, most recently, in Japan. While much is still unknown about the subvariant and what effect it will have on COVID-19s spread, heres what we know so far.
The XE variant is what experts call a recombinant of the BA.1 and BA.2 variants. Its name derives from the X prefix assigned for recombinants, said Stacia Wyman, senior genomics scientist at the Innovative Genomics Institute at UC Berkeley.
The coronavirus group of viruses make recombinants pretty readily, according to Shannon Bennett, chief of science at the California Academy of Sciences. However, whether the recombinant can be detected depends on whether the two parent strains are sufficiently different, she said.
Wyman said the XE subvariant likely arose from a person infected with both the BA.1 and BA.2 versions of the virus. When the virus was replicating, there was an error and the two viruses combined, she explained. Then the combined virus replicates and is spread to other people.
The first part of XEs genome sequence is BA.1, and then changes into BA.2 for the rest of the genome, she said. The S gene, or spike protein which latches onto healthy cells and causes infection comes from BA.2. However, Wyman said its not known yet if someone with a previous BA.2 infection would have some resulting protection from XE.
Since XE is a combination of both BA.1 and BA.2, it shares similarities and differences with both, Bennett said but from a public health standpoint, the variants infectiousness, the ability to evade prior immunity, and transmissibility are still being investigated.
According to a March 25 report from the U.K. Health Security Agency, XE has a growth rate 9.8% above that of BA.2, which Wyman said means it is 9.8% more transmissible. The World Health Organization has previously reported that figure may be 10%, though its still too early for a definitive conclusion.
The XE subvariant was first discovered in the U.K. in mid-January. As of April 5, 1,125 cases had been sequenced there.
In the U.S. so far, according to Wyman, two XE cases have been sequenced in Wisconsin and one in New York. She said Tuesday that she had learned about two unconfirmed cases in California. They had not yet been classified as XE on the international sequencing database GISAID, but have been on genome analysis tools UShER, out of UC Santa Cruz, and NextClade from Switzerlands University of Basel.
The subvariant has also been reported in Thailand, India and Israel, according to news reports. On Monday, Japan announced a traveler arriving from the U.S. was infected with the XE strain and was asymptomatic.
The BA.2 subvariant accounted for 86% of COVID cases in the U.S. for the week ending in April 9, according to the Centers for Disease Control and Prevention. It has quickly outstripped the original omicron variant, BA.1, which was last dominant during the week ending March 12 with 59% of sequenced cases, and led to the pandemics biggest surge so far.
The BA.2 subvariant is causing a spike in cases in the U.S., primarily on the East Coast, which prompted Philadelphia officials this week to reinstate the citys indoor mask mandate. U.S. officials on Wednesday extended the nationwide mask requirement for air travel and public transit, which was set to expire Monday, for another 15 days to allow more time to study and monitor BA.2.
Experts say any new variant that is more transmissible than others has a shot at eventually gaining dominance. Bennett said XE certainly could overtake BA.2, as every variant that takes over is likely to be a better spreader.
But Wyman said she is not too concerned yet about XE.
There is some early evidence that it may be more transmissible than BA.2, but the numbers are too small to draw any definitive conclusions at this time, she said. Its something to keep an eye on, but not for the general population to worry about.
She added that XE may die out completely regionally and never spread, which has occurred with other variants in different regions without clear explanations.
Wyman pointed to another variant, BA.2.12.1, that is being closely monitored in the U.S. According to data from CoV-Spectrum, a COVID variant monitoring platform using data from GISAID, there are 1,119 sequences in the U.S. so far, including 19 in California.
BA.2.12.1 been found in more than half of U.S. states, Wyman said.
We are seeing it spread quite rapidly in the U.S., particularly in New York, she said. The notable difference in this with respect to BA.2 is the addition of the S:L452Q mutation, which has been implicated in immune evasion.
The New York State Department of Health on Wednesday issued an announcement about BA.2.12.1 and another strain, BA.2.12 both sublineages of BA.2 saying they were contributing to a rise in infection rates in the central part of the state.
The Department's findings are the first reported instances of significant community spread due to the new subvariants in the United States, officials said.
The two subvariants are an estimated 23%-27% more transmissible than BA.2, officials said. While at this time, there is no evidence of increased disease severity by these subvariants, officials said, they are watching closely for any changes.
They urged New Yorkers to get fully vaccinated and boosted; mask up in public indoor spaces; get tested after exposure, symptoms or travel; stay home after a positive test and consult their health provider; and improve indoor ventilation or gather outdoors to reduce transmission risk during the Easter and Passover holidays.
Kellie Hwang is a San Francisco Chronicle staff writer. Email: kellie.hwang@sfchronicle.com Twitter: @KellieHwang
On Tuesdays, MinnPost provides weekly updates that cover COVID-19 developments in Minnesota from the previous Wednesday to present.
Weve been saying this for a while, but even as of now, its still kind of pretty unclear whats ahead with BA.2 the more-transmissible stealth omicron subvariant in Minnesota as elsewhere in the United States.
As we discussed last week, BA.2 is dominant here in Minnesota. In the most recent data from the Metropolitan Council, it accounted for two-thirds of the virus detected in Twin Cities wastewater. The same wastewater data suggest a slow and steady rise in viral presence in the region in recent weeks.
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As far as official case counts go, the number of positive cases is up, too, but hospitalization and death data are flat. So, the question weve been asking for weeks remains: How big will this wave be, and will an increase in cases produce as relatively big an increase in hospitalizations and deaths as it did in prior waves?
Under normal circumstances, we might look to the East Coast for clues; East Coast cities have pretty reliably been a couple weeks ahead of Minnesota in terms of COVID-19 surges.
But things are murky there, too. Cases are up, but hospitalizations remain low and deaths are down, the New York Times reports. Those numbers lag behind cases, of course, so it could just be too early to tell if this is the start of a bigger wave or a smaller wave or what.
At-home COVID-19 test reminder: If you havent done so already, you can order free tests through the state here.
Data from the Minnesota Department of Health (MDH) show the state added 3,589 new COVID-19 cases between April 6 and April 12, averaging 513 new cases per day up from last week, which saw an average of 420 cases per day.
As of this week, youll no longer find the seven-day case positivity average in this newsletter. Thats because a federal reporting change means some labs are no longer reporting negative tests to MDH. The state health agency will discontinue reporting the case positivity average this week.
The test results data we are receiving is not as complete as it used to be now that certain negative test results are not required to be reported. This is impacting the positivity rate metric, which is not accurately portraying what it should, MDH spokesperson Andrea Ahneman said in an email explaining the change.
As a result, youll also notice our COVID-19 tracking dashboard no longer includes total tests.
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Minnesota has reported 30 COVID-19 deaths since last Wednesday. Last week, the state reported 29 deaths. (Deaths did not necessarily occur in the week in which they were reported because deaths are not always reported and confirmed immediately.)
COVID-19 ICU hospitalizations are stable compared to last week, while non-ICU hospitalizations have dropped. As of Tuesday, 30 people are in intensive care with COVID-19, while 160 are hospitalized and not in intensive care. Last Tuesday, 29 were in intensive care and 171 were hospitalized and not in intensive care. More information on Minnesotas current hospitalizations here.
The most recent data show 66.3 percent of Minnesotans had completed a COVID-19 primary vaccine series, while 45.9 percent were up-to-date on their shots (meaning they have completed the primary series and received a booster if recommended). A week ago, 66.3 percent of Minnesotans had completed the vaccine series, and 45.8 percent were up-to-date. More data on the states vaccination efforts can be found here.
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People wearing face masks, following the coronavirus disease (COVID-19) outbreak, walk past a closed cinema in Hong Kong, China February 16, 2022. REUTERS/Lam Yik
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HONG KONG, April 14 (Reuters) - Hong Kong confirmed on Thursday it will ease some of the world's most stringent COVID-19 restrictions, allowing beauty parlours, cinemas and gyms to reopen from April 21 as infections in the global financial hub hover below 2,000 per day.
The Chinese-ruled city has been hit by a fifth wave of coronavirus since early this year that has battered business and led to more than 8,600 deaths, many in the past two months, although cases have dropped in recent days.
Coronavirus restrictions have battered businesss and helped fuel a net outflow of around 70,000 people in February and March, up from nearly 17,000 in December, raising concerns over the city's status as a global financial centre. read more
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The government said on Thursday up to four people could gather at any time from April 21, up from two currently, and restaurants could stay open until 10 p.m., extending opening hours for dining venues across the city from 6 p.m. Schools are also due to resume face-to-face classes from next week.
Bars, beaches and barbeque sites remain closed.
"Cases have dropped from a peak of over 70,000 a day to over 1,000 today; if the ... government still doesn't relax (the restrictions), I think it'll have a big impact to Hong Kong's society and economy," Chief Executive Carrie Lam said at a press briefing.
The humber of daily infections in Hong Kong have been below 2,000 for a week, and the city recorded 1,272 cases on Wednesday.
Hong Kong's border has effectively been shut since 2020 with few flights able to land and hardly any passengers allowed to transit, isolating a city that had built a reputation as a global hub.
For some businesses, the relaxations may be too late as many restaurants say they have had to lay off staff as they struggle to pay rent in one of the world's most expensive real estate markets. read more
Until this year, Hong Kong had been far more successful at controlling the coronavirus than many other cities its size, but the latest wave of infections swamped its world-class medical system, and public confidence in the city government is at an all-time low.
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Reporting By Clare Jim and Jessie Pang, Writing by Anne Marie Roantree; Editing by Raju Gopalakrishnan
Our Standards: The Thomson Reuters Trust Principles.
San Antonio could see a short-lived spike in COVID-19 cases due to the BA.2 subvariant of omicron, according to Dr. Bryan Alsip, chief medical officer at University Health.
However, cases and hospitalizations arent rising at the rate they were compared to the previous wave, he said.
BA.2, which the World Health Organization classifies as a variant of concern, now makes up an estimated 86% of infections in the U.S., according to data from the Centers for Disease Control and Prevention.
Locally, BA.2 made up 53% of samples sequenced in Bexar County from March 20 through April 4, said Dr. Marjorie David, director of the Molecular Diagnostic Laboratory at UT Health.
Thats up from less than 8% at the beginning of March, according to the labs COVID-19 genome sequencing surveillance dashboard.
The lab, within UT Healths Department of Pathology, is the only one in the county where pathologists perform genome sequencing to determine variants of the coronavirus.
David said it tests 200 samples every two weeks, randomly selected from area hospital and testing sites, including UT Health San Antonio, University Health System, Community Labs, San Antonio Metropolitan Health District and Methodist Hospital.
We know its here and we know its spreading, said Alsip. However, he pointed out, Our susceptibility to the virus has probably changed.
The variant, immunity and vaccines all play a part in that change, he said.
Variants symptoms present differently as they evolve. BA.2s symptoms are mild, similar to a cold, he said. Some may experience sore throat or congestion. Other times, there may be a low grade fever or more severe symptoms, such as shortness of breath.
This can be confusing as some experience cold or allergy symptoms, which is similar to what may present in the BA.2 subvariant.
The good news is we have these rapid tests that you can take at home, said Alsip. More people can check and make sure they dont have COVID, so that theyre responsible for addressing their infection.
San Antonio was widely impacted by the omicron variant, which drove a surge of cases and hospitalizations. Alsip said this could be an advantage as areas that were significantly impacted by the omicron surge do not seem to be as affected by BA.2.
The good news is [the vaccine] really does prevent severe illness, and then you add on top of that, there is some natural immunity conferred from previous infection, said Alsip.
Alsip warned against depending on that immunity, however, as it wanes over time.
Some groups remain at risk, even during low levels of transmission, including the severely immunocompromised and children under the age of 5, who are not yet eligible for vaccines.
According to the Metropolitan Health Districts COVID-19 weeklyvaccination report, only 35.7% of the population aged 5 years and over have received a booster dose in Bexar County.That mirrors nationwide booster rates, Alsip said.
Unlike live virus vaccines, such as measles or mumps vaccines, the COVID-19 vaccine is an inactive vaccine that does not host a live virus. For that reason, it doesnt last as long as other vaccines, Alsip explained, encouraging booster doses of the covid vaccine.
Lack of interest in booster doses could lead to more infections, he warned.
As of April 5, Metro Health is reporting Bexar Countys risk level as low and steady. Cases continue on a mild, two-week decline, and average case rates, positivity rates and hospitalization trends remain low.
Fosun Diagnostics' Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold) adopted the in- vitro qualitative detection method of Novel Coronavirus (2019-nCoV) Nucleocapsid antigen in nasopharyngeal swabsamples from patients with respiratory and fever-related symptoms within 7 days, quarantine observers, and other antigen detection needs. Fosun Diagnostics' Novel Coronavirus Antigen Detection Kit is equipped with high sensitivity and specificity, strong anti-interference ability and no cross-reactivity among viruses and bacteria. The kit is easy to use and quick to operate and deliver results in 15 minutes. It has a variety of reagents to meet various testing needs at point of demand whenever required.
The product has obtainedthe EU CE certification, duly completed BfArM registration in Germany, and officially endorsed by the EU Health Security Committee Common List (EU common list).
Lately, the State Council's of China under the Joint Prevention & Control for novel coronavirus pneumonia has decided to include antigen detection as a key supplement to nucleic acid detection under the "New Coronavirus Antigen Detection Application Plan (Pilot Trial)". Fosun Diagnostics' Novel Coronavirus Antigen Detection Kit will contribute and continue serving the needs of pandemic prevention and control upon its recent approval.
Adhering to Independent Innovation and Providing Comprehensive Solutions for Covid-19 Nucleic Acid Testing
Since the outbreak of COVID-19, Fosun Pharma as a global innovation-driven pharmaceutical and healthcare group has fully integrated its business and global resources withtimely response actively undertaking our social responsibilities in combating COVID-19 pandemic control.
As one of the Group's key strategic development segments,Fosun Diagnostics independently developed the Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit with the NMPA's approval for emergency use in March 2020 while obtained the Registration Certificate for Medical Device (in vitro diagnostic reagents). Our Covid-19 test kits have also acquired relevant qualifications and certifications in the United States, European Union, Australia and many other countries and regions.
Fosun Diagnostics provides a comprehensive solution of reagents, equipment and consumables for the Novel Coronavirus nucleic acid testing. With clinically-validated, we offer many enhanced advantages in terms of fast and secure, flexible throughput, high sensitivity and reliable results. Fosun Diagnostics' Novel Coronavirus Detection Kit is capable to detect 3 targets (ORF1ab, N and E genes) simultaneously. And our primer probe sequence is independently developed and designed with a sensitivity of up to 300 copies/mL and hence, grossly improved the detection rate for infected people with low virus content or asymptomatic people.
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.
Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, oncolytic viruses, gene therapy and PROTAC, to enhance its innovation capabilities.
Guided by the 4IN strategy (Innovation, Internationalization, Integration, and Intelligentization), Fosun Pharma will uphold the development model of "innovation transformation, integrated operation, and steady growth", with the mission of creating shareholder values as well as promoting the global networks through strengthening its innovative R&D and in-licensing ability and enriching its product pipelines. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global mainstream medical and health market.
For more information, please visit our official website: www.fosunpharma.com.
Fosun Pharma Forward-looking statements
This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including, without limitation, the discussions of Fosun Pharma's business strategies and expectations concerning future operations, margins, profitability, liquidity and capital resources, the future development of Fosun Pharma's industry and the future development of the general economy of Fosun Pharma's key markets and any statements preceded by, followed by or that include words and expressions such as "expect", "seek", "believe", "plan", "intend", "estimate", "project", "anticipate", "may", "will", "would" and "could" or similar words or statements, as they relate to Fosun Pharma'sor its management, are intended to identify forward-looking statements. These statements are subjectto certain known and unknown risks, uncertainties and assumptions, which may cause Fosun Pharma's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Accordingly,you shouldnot placeunduerelianceon any forward-looking information. Subject to the requirements of applicable laws, rules and regulations, Fosun Pharmadoes not have any and undertakes no obligation to update or otherwise revise the forward-looking statements in this press release, whether as a result of new information, future events or developments or otherwise. In this press release, statements of or references to Fosun Pharma's intentions are made as of the date of this press release. Any such intentions may change in light of future developments. All forward-looking statements contained in this press release are qualified by reference to the cautionary statements set outabove.
SOURCE Fosun Pharma
Samantha Castaned, 10, receiving her first dose of the Pfizer vaccine in San Francisco last year.Credit...Mike Kai Chen for The New York Times
A booster shot of the Covid vaccine made by Pfizer-BioNTech increased the level of neutralizing antibodies against both the original version of the virus and the Omicron variant in a small trial of children age 5 to 11, the companies announced on Thursday.
If the companies claims of a strong immune response pass muster with federal regulators, the government could broaden eligibility for booster doses to include 28 million more children.
The study by Pfizer and BioNTech, which the companies described in a brief news release, included 140 children who received a booster dose six months after their second shot.
The children showed a sixfold increase in antibody levels against the original version of the virus one month after receiving the booster shot, compared with one month after receiving a second dose. Laboratory tests of 30 blood samples also showed 36 times the level of neutralizing antibodies against the Omicron variant compared with levels after only two doses, according to the news release and a Pfizer spokeswoman.
The companies said they would ask the Food and Drug Administration for emergency authorization of a booster dose for 5- to 11-year-olds in the coming days. The agency has typically acted within a month of receiving such requests.
Currently, everyone 12 and over in the United States is eligible for at least one booster dose, and about 30 million people age 50 or older are eligible for a second one. Studies suggest that 5- to 11-year-olds may be particularly in need of a booster dose.
Researchers in New York State recently found that while two shots of Pfizers vaccine protected children in that age group from serious illness, they provided virtually no protection against symptomatic infection, even just a month after full immunization.
The companies announcement comes as cases are again ticking up slightly after two months of sustained declines. The upswing has been particularly noticeable in the Northeast, where the BA.2 subvariant, now the dominant version of the virus in the United States, first took hold.
Dr. Anthony S. Fauci, President Bidens chief medical adviser, warned in recent days that the nation could see a significant increase in infections over the next several weeks. But he has said the rates of hospitalizations are unlikely to rise in tandem because so many Americans have a degree of immunity, either from vaccines or prior infections.
Several hundred children age 5 to 11 have died of Covid since the pandemic began, according to the Centers for Disease Control and Prevention, but pediatric shots have been a hard sell for many parents. Only about 28 percent of children in that age group have received two doses and would be eligible for a booster shot. Roughly 7 percent have received just one dose, the agencys data shows.
There was an initial rush for shots after they were first offered for that age group in November, but the increase in the vaccination rate then slowed to a crawl. In the past month, for example, it rose by a single percentage point.
The share of children age 5 to 11 with at least one dose varies starkly by region, according to a study by the Kaiser Family Foundation. Five of the top 10 states with the highest vaccination rates were in New England, while eight out of the 10 states with the lowest rates were in the South.
Even though more than 250 million Americans have been safely vaccinated since the pandemic began, pediatric experts say many parents fear unknown consequences for their children. Compared with shots to protect against measles, mumps and other diseases, which have been around for decades, the Covid vaccines are brand-new.
The study done by New York researchers, posted online in late February, found that for children age 5 to 11, the Pfizer vaccines effectiveness against infection fell to 12 percent from 68 percent within 28 to 34 days after the second dose.
That was a steeper decline than for older adolescents and teens who received a much stronger dose. Some experts suggested that the difference in dosage explained the gap in protection, while others blamed the Omicron variant that was prevalent during the study.
Another study by the C.D.C. stated that two doses of Pfizers vaccine reduced the risk of Omicron infection by 31 percent among those age 5 to 11, compared with a 59 percent reduction in risk among those age 12 to 15.
Pfizers vaccine is so far the only one authorized for those under the age of 18.
Theeleventh meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (2005) (IHR) regarding the coronavirus disease (COVID-19) pandemic took place on Monday 11 April 2022 from 12:00to16:30 Geneva time (CEST).
Members and Advisors of the Emergency Committeewere convened by videoconference.
The Director-General welcomed the Committee members and advisers. The Director-General explained that the world has tools to limit transmission, save lives, and protect health systems. He expressed hope in the current epidemiological situation, noting that the world is currently experiencing the lowest number of reported deaths in two years. However, the unpredictable behavior of the SARS-CoV-2 virus and insufficient national responses are contributing to the continued global pandemic context. The Director-General emphasized the importance of States Parties using available medical countermeasures and public health and social measures (PHSM). He highlighted the publication of the updated Strategic Preparedness, Readiness, and Response Plan which provides a roadmap for how the world can end the COVID-19 emergency in 2022 and prepare for future events.
Representatives of the Office of Legal Counsel (LEG) and the Department of Compliance, Risk Management, and Ethics (CRE) briefed the members on their roles and responsibilities. The Ethics Officer from CRE provided the members and advisers with an overview of the WHO Declaration of Interests process. The members and advisers were made aware of their individual responsibility to disclose to WHO, in a timely manner, any interests of a personal, professional, financial, intellectual or commercial nature that may give rise to a perceived or direct conflict of interest. They were additionally reminded of their duty to maintain the confidentiality of the meeting discussions and the work of the Committee. Each member who was present was surveyed. No conflicts of interest were identified.
The Secretariat turned the meeting over to the Chair, Professor Didier Houssin, who reviewed the objectives and agenda of the meeting.
The Secretariat presented on the current status of the COVID-19 pandemic and a vision for how to optimize the ongoing response to the COVID-19 pandemic for 2022. The presentation focused on:
The Committee discussed key issues including SARS-CoV-2 variants; use and equitable access to antivirals; vaccine protection and global shifts in the supply and demand for COVID-19 vaccines; hybrid immunity; potential future scenarios for SARS-CoV-2 transmission and challenges posed by concurrent health emergencies; and how Member States are responding to the COVID-19 pandemic. The Committee also noted with concern the growing fatigue among communities worldwide in response to the COVID-19 pandemic and challenges posed by the lack of trust in scientific guidance and governments.
The Committee recognized that SARS-CoV-2 is a novel respiratory pathogen that has not yet established its ecological niche. SARS-CoV-2 continues to have unpredictable viral evolution, which is compounded by its wide-spread circulation and intense transmission in humans, as well as widespread introduction of infection to a range of animal species with potential for animal reservoirs to be established. SARS-COV-2 is continuing to cause high levels of morbidity and mortality, particularly among vulnerable human populations. In this context, the Committee raised concerns that the inappropriate use of antivirals may lead to the emergence of drug-resistant variants. In addition, Committee members acknowledged national, regional, and global capacities to respond to the COVID-19 pandemic context, but noted with concern that some States Parties have relaxed PHSM and reduced testing, impacting thus the global ability to monitor evolution of the virus. The Committee also noted with concern the inconsistency of global COVID-19 requirements for international travel and the negative impact that inappropriate measures may have on all forms of international travel. In this context, the Committee noted that offering vaccination to high-risk groups of international travelers on arrival could be considered a means to mitigate the risk of severe disease or death due to COVID-19 among these individuals.
The Committee stressed the importance of maintaining PHSM to protect vulnerable populations, and maintaining the capacity to scale up PHSM if the epidemiological situation changes. States Parties are advised to regularly adjust their response strategies by monitoring their epidemiological situation (including through use of rapid tests), assessing their health system capacity, and considering the adherence to and attributable impact of individual and combined PHSM.
In addition, the Committee reinforced the continued need for international cooperation and coordination for surveillance, as well as for robust and timely reporting to global systems (such as the Global Influenza Surveillance and Response System) to inform national, regional, and global response efforts. Surveillance activities require coordination between the human and animal sectors and more global attention on the detection of animal infections and possible reservoirs among domestic and wild animals. Timely and systematic monitoring and data sharing on SARS-CoV-2 infection, transmission and evolution in humans and animals will assist global understanding of the virus epidemiology and ecology, the emergence of new variants, their timely identification, and assessment of their public health risks. Continued provision of technical support and guidance from all three levels of the WHO can enable States Parties adjustment of COVID-19 surveillance and its integration into respiratory pathogen surveillance systems.
The Committee acknowledged that COVID-19 vaccination is a key tool to reduce morbidity and mortality and reinforced the importance of vaccination (primary series and booster doses, including through heterologous vaccine schedules). The Committee expressed appreciation for WHO and partners work to enhance global vaccine supply and distribution. Committee members highlighted the challenges posed by limited vaccination protection, particularly in low-income countries, as well as by waning population-level immunity. As outlined in the SAGE roadmap, vaccination should be prioritized for high-risk groups such as health workers, older adults, and immune-compromised populations, refugees, and migrants. To enhance vaccine uptake, States Parties are encouraged to address national and sub-national barriers for vaccine deployment and to ensure COVID-19 response measures align with and strengthen immunization activities and primary health services.
In addition, the Committee noted the continued importance of WHOs provision of guidance, training, and tools to support States Parties recovery planning process from the COVID-19 pandemic and future respiratory pathogen pandemic preparedness planning.
The Committee unanimously agreed that the COVID-19 pandemic still constitutes an extraordinary event that continues to adversely affect the health of populations around the world, poses an ongoing risk of international spread and interference with international traffic, and requires a coordinated international response. The Committee stressed the importance for States Parties to prepare for future scenarios with the assistance of WHO and to continue robust use of the essential tools (e.g. vaccines, therapeutics, and diagnostics). The Committee concurred that the COVID-19 pandemic remains a PHEIC and offered its advice to the Director-General.
The Director-General determined that the COVID-19 pandemic continues to constitute a PHEIC. He accepted the advice of the Committee and issued the Committees advice to States Parties as Temporary Recommendations under the IHR.
The Emergency Committee will be reconvened within three months or earlier,at the discretion of the Director-General.The Director-General thanked the Committee for its work.
Temporary Recommendations to States Parties
The Committee identified the following actions as critical for all countries:
U.S. Rep. Gwen Moore announced late Wednesdaythat she has tested positive for COVID-19.
Earlier in the day, Moore attended and spoke at Mayor Cavalier Johnson's inauguration.
"Today, I was experiencing very mild symptoms associated with COVID-19. I got tested as a precaution and tested positive for COVID-19,"Moore said in a statement.
Johnson's swearing-in at the Harley-Davidson Museum was attended by manyof the state's highest-ranking Democrats, including Gov. Tony Evers, U.S. Sen. Tammy Baldwin, Lt. Gov. Mandela Barnes and Milwaukee County Executive David Crowley.
Moore previously tested positive in December 2020.In January 2021, she announced she was cleared to return to work after six days.
Her positive test joins agrowing list of Washington officials who are testing positive for COVID-19.The House was in session last week but house membersare under a home district work schedulethis week, according to itsschedule.
Moore is vaccinated and said she is quarantining.
"I am following guidance from my doctors and quarantining. Please remain vigilant against COVID-19 by wearing a mask, getting vaccinated, and practicing social distancing when possible," she said.
Contact Drake Bentley at (414) 391-5647 orDBentley1@gannett.com. Follow him on Twitter at @DrakeBentleyMJS.
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