A vial labelled with the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/File Photo
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Dec 16 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE said on Thursday they have filed for full approval of their COVID-19 vaccine with the U.S. Food and Drug Administration to include adolescents aged 12 to 15.
The vaccine received full approval for ages 16 and above in the United States in August. The shot also has an emergency use authorization for 5 to 15 year olds.
Pfizer is seeking for an approval based on long-term data from a late-stage study conducted among adolescents. The company said in November the two-dose series of the vaccine was 100% effective against COVID-19, measured seven days through over four months after the second dose.
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The company is seeking clearance for a 30 micrograms dose of the vaccine for those aged 12 and above. Pfizer/BioNTech's vaccine is the only COVID-19 vaccine authorized for the given age group in the U.S.
Pfizer said it expects to file for approval with the European Medicines Agency and other regulatory authorities around the world in the coming weeks.
The FDA gave the two-dose vaccine emergency-use authorization for adolescents in May.
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Reporting by Dania Nadeem in Bengaluru; Editing by Aditya Soni and Shounak Dasgupta
Our Standards: The Thomson Reuters Trust Principles.
Johnson & Johnson temporarily halted production of its COVID-19 vaccine in the Netherlands, the only manufacturing hub making usable doses for the pharmaceutical company, according to a New York Times report on Tuesday.
The company stopped production of the vaccine at its facility in the Dutch city of Leiden at the end of 2021 and has instead turned its attention to making another vaccine for an unrelated virus, the Times reported. The pause is temporary and is expected to last just a month but it could reduce Johnson& Johnson's vaccine supply by a few hundred million doses.
While the Johnson & Johnson vaccine from Janssen Pharmaceuticals has been linked to rare blood clots and is considered less effective than Pfizer's and Moderna's shots by the Centers for Disease Control and Prevention,it is extremely important in Africa and low-income countries, which rely on the simpler one-dose shot.
The vaccine also avoids the requirement of storage in ultra-cold temperatures, which makes shipment of Moderna and Pfizer doses more difficult.
In October, Johnson & Johnson said it was committing about 50 million vaccines to 40 countries through COVAX, the vaccine-sharing initiative from the World Health Organization and the United Nations.
ButAyoade Alakija, a co-head of the African Unions vaccine-delivery program, told the Times that switching up production could endanger the vaccination effort.
This is not the time to be switching production lines of anything, when the lives of people across the developing world hang in the balance, she said.
A spokesperson for the company told The Hill that millions of doses were in inventory and they were still planning to "fulfill our contractual obligations" related to COVAX and the African Union.
"We strive to improve human health and have worked tirelessly to forge partnerships and build a global manufacturing network across four continents to produce our COVID-19 vaccine. In addition, we expanded the capacity of our facility in Leiden in 2021, and the site continues to play a role in our vaccine manufacturing in 2022," the spokesperson said.
"Our manufacturing sites produce multiple products as we have an obligation to supply life changing medicines to patients around the world and bring forward our innovative pipeline of new medicines and vaccines. We manage our production planning accordingly and are currently supplying from our extensive global network based on the demand for our vaccine and the needs of our patients and customers," the spokesperson added.
Millions of Americans have received Johnson & Johnson's vaccine, and the companyearned $2.39 billion in vaccine sales in 2021.Johnson& Johnson is estimating even higher sales in 2022, ranging between $3 billion and $3.5 billion.
According to the report from the Times, Johnson & Johnson is planning to revive three other manufacturing plants to produce its COVID-19 vaccine, including a facility in Baltimore that was shut down in April following a failure to meet federal guidelines.
Updated at 3:59 p.m.
When the COVID-19 vaccines became available, many health care workers, despite seeing the devastating effects of the virus firsthand, said they did not intend to get vaccinated. But a new Northwestern Medicine study shows how quickly many of them at a large urban health care system changed their minds, resulting in a vaccination rate of 95% by spring 2021.
The study found:
This study found health care workers attitudes about COVID-19 vaccination could change in a very short period of time, said lead study author Charlesnika Evans, professor of preventive medicine in epidemiology at Northwestern University Feinberg School of Medicine. It shows there is opportunity to change peoples decisions about not getting vaccinated.
The study was recently published in the journal Infection Control & Hospital Epidemiology.
The first survey for this analysis was administered to 4,180 Northwestern Medicine health care workers who enrolled in the study in December 2020 through February 2021. The second survey was in June 2021. The survey asked about health care workers COVID-19 exposures and experiences and COVID-19 vaccination status. The participants also underwent blood testing to measure their antibodies at enrollment in spring 2020 and six months after enrollment.
Multiple factors likely contributed to health care workers changing their minds, Evans said. They included clear messaging about the safety of the vaccines, convenient access to vaccinations at the hospital, awareness that workplace mandates were coming in the future, as was the Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration.
We saw a significant change in the number of people who said they would get the vaccine after the EUA was issued. People may have felt, OK, this might be safe for me to take.
Gender, race, and occupation played a role in vaccination acceptance, the study showed. Nurses (versus physicians), non-Hispanic Black (versus Asian) health care workers, and women versus men were less likely to report an intention to get vaccinated.
Individuals who showed negative antibody results were more likely to get vaccinated. People older than 65 years of age were more likely to get vaccinated. Women had a lower intention to get vaccinated than men, especially those who were in their reproductive years. Nurses also had lower intentions to get the vaccine, despite the reports that nurses have the highest rates of COVID-19 within health care workers.
One way to address mistrust is including people who have not traditionally been in research studies, making more of an effort to include them in vaccine or research studies in general, Evans said.
The fact that they didnt actively recruit pregnant women into the vaccine studies makes sense early on, but to prove and be sure its safe and effective, inclusion of these groups in trials is important, Evans said. However, so far CDC data show that pregnant women have not experienced more adverse events than the general population.
Furthermore, while a good portion of Black participants in the study eventually got vaccinated, mistrust in the health care system is a concern, Evans said.
Thats a larger issue to be addressed within society in general that goes way beyond this study, Evans said. We must continue thinking about how to improve our messaging and addressing the issues around mistrust toward the health care system. This is imperative for COVID-19 and other conditions.
Reference: Coronavirus disease 2019 (COVID-19) vaccine intentions and uptake in a tertiary-care healthcare system: A longitudinal study by Charlesnika T. Evans, Benjamin J. DeYoung, Elizabeth L. Gray, Amisha Wallia, Joyce Ho, Mercedes Carnethon, Teresa R. Zembower, Lisa R. Hirschhorn and John T. Wilkins, 27 December 2021, Infection Control and Hospital Epidemiology.DOI: 10.1017/ice.2021.523
Northwestern authors are principal investigator John Wilkins and co-authors Benjamin DeYoung, Elizabeth Gray, Amisha Wallia, Joyce Ho, Mercedes Carnethon, Teresa Zembower and Lisa Hirschhorn.
The research was funded by Northwestern University Clinical and Translational Sciences Institute (UL1TR001422) and the Northwestern Memorial Foundation.
In the wake of a U.S. Supreme Court ruling blocking the Biden administration's COVID-19 vaccine and testing mandatefor private companies, the electronic health record vendor athenahealth has sought to clarify its own rules for employees.
"Our current policy includes testing options and requirement for vaccination for some employees, based on job function," athenahealth representatives told Healthcare IT News this week.
That policy is not based on office location.
In response to follow-up inquiries about how many employees, and which job functions, were subject to the mandatory vaccination policy, the representatives characterized the group as "a limited number of employees including those who travel to interact with clients or prospects."
"The vast majority of our employees are vaccinated," said the representatives.
WHY IT MATTERS
The company's worker vaccination policy has been the subject of some recent confusion, according to local reporting.
The Republican Journal in Waldo County, Maine, where the company has a campus in Belfast, said that some employees had been under the impression that vaccination by April 1 was mandatory.
However, the employees told the outlet that the company revised this stance via a statement in late January, saying vaccinations were not mandatory for those who don't interact with clients.
As of Tuesday, 70.13% of Waldo County residents were considered fully vaccinated lower than the state rate of 76.48%, but higher than the national percentage.
athenahealth representatives told Healthcare IT News that the current plan is to return to in-person work in June.
For employees who dont wish to work in person because of the vaccine policy, athenahealth said that it "will provide reasonable accommodations on a case-by-case basis."
THE LARGER TREND
Other EHR vendors in the industry have taken differing approaches to employee vaccinations and work-from-home options.
In August 2021, Epic announced that all U.S. employees would be required to be fully vaccinated by October 1. Around the same time, it said that employees would need to return to the office nearly full time.
Meanwhile, Cerner announced its own vaccine mandate this past October, along with a hybrid in-person and virtual model for workers. It's unclear as of yet if the company's recently announced acquisition by Oracle will affect either policy.
ON THE RECORD
"We continue to evaluate our policy and make decisions based on evolving public health guidance, and legal and business considerations," said athenahealth representatives.
Kat Jercich is senior editor of Healthcare IT News.Twitter: @kjercichEmail: kjercich@himss.orgHealthcare IT News is a HIMSS Media publication.
As Pfizer Inc. forecasts strong sales this year for its Covid-19 vaccine and treatment, the drugmaker is on the hunt for deals to bolster its pipeline of experimental products.
Pfizer said Tuesday that surging sales of its Covid-19 treatment and continued demand for its shots should boost the companys revenue to around $100 billion this year. The company estimated that sales of its antiviral pill Paxlovid will reach about $22 billion while the vaccine will add $32 billion.
The study covered in this summary was published in medRxiv.org as a preprint and has not yet been peer reviewed.
There was only a minimal increase in antibody titers and seroconversion seen after the third SARS-CoV-2 mRNA vaccine in patients with multiple sclerosis who had been treated with the anti-CD20 therapy, ocrelizumab, as compared with healthy controls.
The time intervals between the ocrelizumab dose and the third vaccine dose did not correlate with antibody levels.
Patients with multiple sclerosis who are being treated with anti-CD20 are at high risk of severe complications from SARS-CoV-2 infection; therefore, it is important to have a vaccine that confers lasting protective immunity to this virus.
The findings from this study point to the need for a way to increase B cells in these patients, possibly by using monoclonal antibodies or other ways of repleting the B cells prior to SARS-CoV-2 vaccination.
This was a prospective, longitudinal, observational study that included patients 18 years of age or older with multiple sclerosis who were being treated with anti-CD20 (ocrelizumab).
The patients were seen at one of two Danish clinics or the Multiple Sclerosis and Neuroinflammation Center at the University of California, San Francisco.
The patients had already received two doses of the SARS-CoV-2 mRNA vaccine and were eligible for a third (booster) vaccine.
Blood samples to measure the IgG antibody levels of the SARS-CoV-2 spike receptor binding domain were taken before and after all three doses of the vaccine.
Measurements of B cells, T cells, and spike-specific T-cell responses were also done.
Detectable antibodies were found in 14% of the participants 07 days before the second vaccine; this increased to 37.7% by 24 weeks after that vaccine. It then decreased to 24.0% at 07 days before the third vaccine; 33.3% of the patients who had antibodies at the 2- to 4-week point had no antibodies by 07 days before the third vaccine.
The antibodies were significantly lower at the 0- to 7-day point than they were at the 2- to 4-week postsecond vaccine point (P = .0020).
Following the third vaccine, 33.3% of the participants had positive antibodies, with 25.6% of participants having detectable antibodies at both 24 weeks after the second vaccine and 24 weeks after the third vaccine. Of the participants who did not have detectable antibodies prior to the third dose, 13.2% had detectable levels after the third vaccine.
Regarding the levels of antibodies needed for protection against infection, 7.4% of the participants had low levels that would confer less than 50% protection; 24% had intermediate levels, giving above 50% protection; and 1.8% (only one patient) had high levels, giving more than 80% protection.
The levels of B cells and T cells were not different between the patients who had detectable antibodies (seropositive) and those who did not (seronegative) 07 days before the third booster.
The frequencies of the spike-reactive T cells increased from before the first vaccine compared with after the second vaccine; however, there was only a slight increase after the third vaccine.
The median age of the participants did not differ between the seropositive and seronegative individuals (P = .2254).
The interval between the time a patient received their last dose of ocrelizumab and their third vaccine dose did not correlate with their antibody levels (r2 = 0.04008, P = .44).
Additionally, the interval between the second and third vaccine doses did not correlate with the patient's antibody levels (r2 = 0.00097, P = .90).
The time frame used was short; therefore, there were missing samples at the last two blood collections (07 days before the third booster vaccination and 24 weeks after the third booster vaccination).
The levels of responses used as cutoffs were based on the previous variants of SARS-CoV-2; they did not include the Delta or Omicron variants.
This study was conducted with fundings from the Danish Neurological Society, Lundbeck, and Roche.
Joseph J. Sabatino, Jr, has received research support from Novartis.
Riley Bove has received research support from Biogen, Roche Genentech, and Novartis; has received personal consulting fees from Alexion, Biogen, EMD Serono, Novartis, Roche Genentech, and Sanofi Genentech; and is funded by a Harry Weaver Award from the National Multiple Sclerosis Society and the National Institutes of Health.
Scott S. Zamvil has received consulting honoraria from Alexion, Biogen-Idec, EMD-Serono, Genzyme, Novartis, Roche/Genentech, and Teva Pharmaceuticals, Inc, and has served on data safety monitoring boards for Lilly, BioMS, Teva, and Therapeutics.
Tobias Sejbaek has received travel grants from Biogen, Merck, Novartis, and Roche; has received research grants from Biogen; and has served on advisory boards for Biogen, Merck, and Novartis.
Hamza Mahmood Bajwa, Frederik Novak, Anna Christine Nilsson, Keld-Erik Byg, Isik S. Johansen, Christian Nielsen, Dorte K. Holm, A. B. Jacobsen, Kristen Mittl, and William Rowles have disclosed no relevant financial relationships.
This is a summary of a preprint research study, "Persistently Reduced Humoral and Cellular Immune Response Following Third SARS-CoV-2 mRNA Vaccination in Anti-CD20-Treated Multiple Sclerosis Patients," written by Hamza Mahmood Bajwa and colleagues from the Department of Neurology, Hospital Southwest Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark, and the Department of Regional Health Research, University of Southern Denmark, Odense, Denmark, on medRxiv, provided to you by Medscape. This study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.
Credits:
Lead Image: NIH
Medscape Medical News2022
Send news tips to news@medscape.net.
Cite this: Is Protection Conferred by Third COVID-19 Vaccine in Patients With MS?-Medscape-Feb08,2022.
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Boston Mayor Michelle Wu on Tuesday defined a set of public health metrics that, when achieved, would trigger an end to the city's COVID-19 vaccination requirement for indoor businesses. The rule, known as the "B Together" policy, will remain in place until the Boston Public Health Commission reports the city has met three conditions:Fewer than 95% of ICU beds are occupiedFewer than 200 COVID-19 hospitalizations per dayA community positivity rate below 5%, as defined by the Boston Public Health Commissions 7-day moving average"We have continued to see trends in the right direction. The reporting that happens on a weekly basis shows that our city-wide community positive rate is a little over 7%," Wu said during an event Tuesday morning. "Boston Public Health Commission has set three key thresholds for those metrics and as those metrics change, we are looking to adjust our policies, as well."Wu first announced the vaccination requirement in December, and it took effect on Jan. 15. Patrons 12 and older are required to show they have received at least one vaccine dose to enter indoor dining, bars, nightclubs, gyms and entertainment venues. Proof of full vaccination will be required for adults by Feb. 15.When the three metrics are achieved, Wu said the policy will be lifted but it could be restored if the pandemic surges again in the future.Wu added Tuesday that the city is focused on closing the gap in disparities in the pediatric vaccination rate. She said the city is planning to focus on getting more children vaccinated during the February school vacation.The mask mandate, we are not yet there in terms of pulling, Wu said. "We had lots of conversations about other policies in place."Outgoing Boston Public Schools Superintendent Brenda Cassellius said the mask mandate for city schools will also continue.We are going to continue to look at (Department of Elementary and Secondary Education) guidance around mask mandates, as well as the city of Boston, Cassellius said. Right now, we are holding with our current policies that we have at this time.
Boston Mayor Michelle Wu on Tuesday defined a set of public health metrics that, when achieved, would trigger an end to the city's COVID-19 vaccination requirement for indoor businesses.
The rule, known as the "B Together" policy, will remain in place until the Boston Public Health Commission reports the city has met three conditions:
"We have continued to see trends in the right direction. The reporting that happens on a weekly basis shows that our city-wide community positive rate is a little over 7%," Wu said during an event Tuesday morning. "Boston Public Health Commission has set three key thresholds for those metrics and as those metrics change, we are looking to adjust our policies, as well."
Wu first announced the vaccination requirement in December, and it took effect on Jan. 15.
Patrons 12 and older are required to show they have received at least one vaccine dose to enter indoor dining, bars, nightclubs, gyms and entertainment venues. Proof of full vaccination will be required for adults by Feb. 15.
When the three metrics are achieved, Wu said the policy will be lifted but it could be restored if the pandemic surges again in the future.
Wu added Tuesday that the city is focused on closing the gap in disparities in the pediatric vaccination rate. She said the city is planning to focus on getting more children vaccinated during the February school vacation.
The mask mandate, we are not yet there in terms of pulling, Wu said. "We had lots of conversations about other policies in place."
Outgoing Boston Public Schools Superintendent Brenda Cassellius said the mask mandate for city schools will also continue.
We are going to continue to look at (Department of Elementary and Secondary Education) guidance around mask mandates, as well as the city of Boston, Cassellius said. Right now, we are holding with our current policies that we have at this time.
For immediate release: February 3, 2022(22-023)Spanish
Contact: DOH Communications
Public inquiries: State COVID-19 Information Hotline, 1-800-525-0127
People who are immunocompromised are especially vulnerable to COVID-19
OLYMPIA A fourth dose of COVID-19 vaccine can help some people with weakened immune systems be less likely to catch COVID-19 and get severely ill. Certain individuals who are immunocompromised may receive up to four doses of COVID-19 vaccine, which includes two primary doses of an mRNA vaccine (Pfizer-BioNTech or Moderna), an additional primary dose, and a booster dose.
The Centers for Disease Control and Prevention (CDC) recommends people ages 5 and older who are moderately or severely immunocompromised should get an additional primary shot (third dose) of an mRNA vaccine 28 days after receiving their second dose. An additional primary shot may prevent serious and possibly life-threatening COVID-19 in people who may not have responded well to their two-dose mRNA COVID-19 vaccine primary series. Currently, no additional primary shot is recommended for people who received the Johnson & Johnson vaccine.
Everyone 12 years of age and older, including immunocompromised people, should get a booster shot when they are eligible. Those who received Pfizer or Moderna should get a booster 5 months after completing their primary series and people who received the single-shot Johnson & Johnson vaccine should get a booster 2 months after their first dose.
COVID-19 vaccines are safe and effective, but some immunocompromised individuals dont get strong enough immunity following their initial two-dose series, said Dr. Tao Sheng Kwan-Gett, MD, MPH, Chief Science Officer. Receiving an additional primary dose and a booster dose will help protect those who are more susceptible to the disease. Getting everyone up to date on all vaccine doses they are eligible to receive can also help protect the most vulnerable in our communities.
According to the CDC, people are considered moderately or severely immunocompromised if they have:
People should talk to their trusted healthcare provider about their medical condition, and whether getting an additional primary shot is appropriate for them. For more information, visit the Frequently Asked Questions section of the Washington State Department of Healths website.
The DOHwebsite is your source for a healthy dose of information. Find us on Facebook and follow us on Twitter. Sign up for the DOH blog,Public Health Connection.
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