Category: Covid-19 Vaccine

For Immediate Release: June 11, 2021

Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available.

The agency is announcing today that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.

The FDAs decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries. A condition on any export of these batches, or of vaccine manufactured from these batches, is that Janssen and Emergent agree that the FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used.

The FDA has also revised the letter of authorization for the Janssen vaccine to help facilitate potential export to other countries. Under the revised letter of authorization, the distribution and administration of exported vaccines must comply with the laws of the recipient countries.

The FDA has determined several other batches are not suitable for use, but additional batches are still under review and the agency will keep the public informed as those reviews are completed.

Additionally, the FDA has extended the expiration dating for the refrigerated Janssen COVID-19 Vaccine after reviewing information submitted by Janssen and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months instead of 3 months.

These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product. This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDAs current good manufacturing practice requirements, said Peter Marks, M.D. Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Additionally, the action to extend the shelf life for the refrigerated Janssen vaccine means that jurisdictions that have doses on hand now have additional time to administer vaccine.

The FDA also will keep the public and our global partners informed as we continue to work expeditiously on this issue and will share information when we are able.

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Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

06/11/2021

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FDA Takes Steps to Increase Availability of COVID-19 Vaccine | FDA - FDA.gov

MIAMI (CBSMiami)

Cancer treatment can affect the immune system, which can leave patients susceptible to infections.

Many medical groups recommend most cancer patients and survivors receive the COVID-19 vaccine, but there are some questions about the effectiveness of the shot for this group.

Researchers at The Ohio State University Comprehensive Cancer Center have launched a study to understand how the vaccine impacts those patients.

There are some patients where were not measuring as good an antibody response as what we would like to see, says Dr. Peter Shields who is leading the study. However, we have no idea whether or not thats still sufficiently protective. So, there may very well be a subset of patients who need to get boosters more often. This is what were trying to figure out.

Vaccinated patients with and without cancer have been enrolled in the study. Participants provide weekly saliva samples to test for COVID and blood samples to measure immune response.

Dave Hill is taking part in the research. This is one thing that came in that allowed me to participate and pay back to those people who helped me and who are helping others, he said.

Even before the pandemic, the 63-year-old had to isolate himself after receiving intense chemotherapy and then a stem cell transplant for lymphoma.

Ive been doing this since mid-2018. And I said, so if you think your stir crazy, you should be in my shoes, Hill says.

The stakes got even higher when COVID hit.

There was an extremely high anxiety about any kind of infection. I just had to continue to be very diligent, Hill said.

He hopes the vaccine protects him and everybody else.

Read more:

Effectiveness of COVID-19 vaccine in cancer patients, survivors studied - Wink News

But, Bacharach said, there is a labor shortage in many industries, including nursing homes and other health care facilities, as well as in retail. So maybe they will require new workers to get vaccinated but not push existing workers. For them, the employers may be more likely to offer incentives.

Continue reading here:

Maryland companies, retailers say they wont make COVID-19 vaccinations mandatory for workers, at least not yet - Baltimore Sun

DENVER (KDVR) Its a question on the minds of many Colorado parents: if my kid is approved for the COVID-19 vaccine, can they also receive other vaccinations at the same time?

According to experts at UCHealth, the answer is yes.

The CDC changed its guidelines allowing for the co-administration of vaccines and its something the American Academy of Pediatrics supports too.

It is generally recommended if youre going to get multiple vaccines that you sort of distribute them on different arms so that [your child is] not completely in pain the rest of the day. But yeah, you can get a COVID shot, a flu shot whatever they need you can get them all at the same time, said Dr. Michelle Barron, Senior Medical Director of Infection Prevention & Control at UCHealth.

As things currently stand, children 12 and over are eligible to receive the vaccine here in Colorado.

According to CDC data, since the pandemic started over 1.5 million adolescents between the ages of 12-17 years old have been diagnosed with COVID-19; more than 13,000 have been hospitalized.

In fact, when you look at the current data in our state: age groups contracting the virus have shifted.

Its not the over 70 crowd getting infected as frequently, rather were seeing higher rates of 12-15 year olds.

Since many of these kids also need to get shots for things like Chickenpox, DTaP (Diphtheria, Tetanus, Pertussis)and Measles before heading back to school, experts want you to know lumping in the COVID-19 vaccine wont impact any other vaccines effectiveness.

The good news for kids: many other vaccinations are now compiled into one shot.

The nice thing is that theres actually combinations of them. So now they dont have to get individual shots like Measles, Mumps, Chicken Pox, so youre getting them all at once. So you can just get your shot right then and there which is nice for them, said Dr. Barron.

While children ages 12 and older are currently eligible to get vaccinated, Dr. Barron says around August or September theyre anticipating kids between the ages of 5 and 11 will be eligible too.

Read the original:

Yes, your child can get the COVID-19 vaccine on top of other vaccines - FOX 31 Denver

Delayed Large Local Reactions to mRNA Covid-19 Vaccines in Blacks, Indigenous Persons, and People of Color | NEJM  nejm.org

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Delayed Large Local Reactions to mRNA Covid-19 Vaccines in Blacks, Indigenous Persons, and People of Color | NEJM - nejm.org

Michigan crossed the 60% threshold for residents 16 years and older who have received at least a first dose of COVID-19 vaccine.

As of Thursday, June 10, more than 4.86 million residents have gotten their first dose of vaccine. The state is 806,870 residents away from hitting its goal of reaching 70% partially vaccinated.

The milestone comes as coronavirus cases, hospitalizations and positive test rates continue to dip into lows not seen since last summer.

Thanks to every Michiganderwho stepped up to keep themselves, their family, and their community safe, Whitmer said via a prepared statement Friday, June 11. We can all feel a sense of optimism thanks to the tireless efforts of countless frontline workers who put their own safety on the line to keep the rest of us going. And we are tremendously grateful to the medical community who kept us all safe andcreatedthe safe, effective vaccines, all miracles of modern science.

As we crossthe60% milestone in vaccinations, we are seeing cases, deaths, and hospitalizations continue to fall fast,which has helped to poise our economy for astrong recovery. I know that we can give Michigan the economic jumpstart it needs with the billions in available federal fundsand our multi-billion dollarbudget surplus. We will emerge from this once-in-a-century pandemic stronger than ever, and I am confident that we can make lasting, transformative investments in our schools, small businesses, and communities to help them thrive.

Related: Michigans affluent neighborhoods are three times more likely to be vaccinated than poor areas

While Michigan has set its goals around getting residents at least partially vaccinated, health officials recommend getting two doses of the Pfizer or Moderna shots for maximum efficacy. In Michigan, 48.7% of residents 12 years and older have completed their vaccination -- or nearly 4.19 million people -- compared to 54.8% of residents in that age range who have started their dosage.

Below is a breakdown by age group of Michigan residents who have gotten at least one dose of vaccine and those who are fully immunized.

Under the states prior reopening plan, the lifting of restrictions on businesses were tied to reaching vaccination milestones including one for reaching 60%. At that time, indoor capacity at sports stadiums would have increased to 25%; indoor capacity at conference centers, banquet halls and funeral homes would have increased to 25%; gym capacity would have moved to 50%; and bars and restaurants would no longer be required to close early.

However, the governor pivoted after receiving new guidance from the CDC in mid-May. Instead, Michigan chose to lift its COVID-19 restrictions in two steps -- one on June 1 and the other on July 1.

As of June 1, all outdoor capacity limits were removed, curfews on bars and restaurants were lifted, and all indoor settings were allowed 50% capacity. Beginning July 1, those capacity restrictions, as well as the mask mandate for individuals not fully vaccinated, will be lifted.

Lt. Gov. Garlin Gilchrist II also expressed his appreciation for the continued effort to get residents vaccinated Friday, via a press release.

I ampleased to see thatsomany Michiganders arecontinuing to makethe choice to get vaccinated.Thank you to every person who has had a conversation with someone in their lifeto encourage them to get vaccinated, and theprofessionals and volunteers who have made vaccines available everywhere in our state, he said.

These safe, effectivevaccinesareour best shot to end this pandemic on our own terms. As more Michiganders make that choice, wecome closer and closer toconfidentlygrowingour economyacross the board, and setting our path toward a stronger Michigan.As we reach these vaccine milestones, were ableto hug our families, return to offices,enjoy a dinner out at our favorite restaurant, andsafelyspendtime withfriends.

Vaccine appointments, including walk-ins, are available throughout the state for individuals 12 years and older. For more information, visit thestates COVID-19 vaccine website.

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View original post here:

Michigan hits 60% milestone for residents partially vaccinated against COVID-19 - MLive.com

PRESQUE ISLE Northern Light AR Gould Hospital is continuing to adapt COVID-19 vaccine opportunities to make getting a vaccine as convenient as possible for community members. Starting on Monday, June 14, these vaccines will now be offered at all of the hospitals primary care and pediatric locations, as well as in its OB/GYN practice. Additionally, hours for vaccines in Walk-In Care locations have been greatly extended.

When the hospital closed its mass vaccination site at Northern Maine Community College last month, they began offering vaccines at their Walk-In Care locations in Caribou and Presque Isle for designated times two days a week. Beginning on June 14, individuals can present to either location whenever they are open to get their vaccine. The Caribou Walk-In on Bennett Drive is open seven days a week from noon to 8 p.m.; the site on North Street in Presque Isle is open daily from 8 a.m. to 8 p.m. No appointment or pre-registration is necessary. The Pfizer vaccine will be offered, so it is available to anyone age 12 and older, whether or not they are a Northern Light Health patient.

In addition to extending vaccine availability to seven days a week at Walk-In Care, the hospital will also begin offering vaccines in its primary care, pediatric, and OB/GYN practices starting that same day (Monday, June 14). Patients can request the vaccine when they are being seen for an appointment; walk-in opportunities for individuals (whether or not a patient) will also be an option. People can reach out to the practice they wish to go to in order to learn more specific details.

The Pfizer vaccine will be offered in the pediatric practice locations in both Presque Isle and Caribou, at the primary care office in Caribou, and at both the Womens Health Center and OB/GYN practices in Presque Isle.

The one-shot Johnson & Johnson vaccine will be offered at primary care offices in Presque Isle, Fort Fairfield and Mars Hill.

The hospital has continued to adapt plans and services throughout the COVID-19 pandemic to meet the needs of the community. Being able to adapt quickly to ever-changing rules, procedures, and needs has been the hallmark of the hospitals response efforts.

When we first started, it was all about getting as many people as possible vaccinated as quickly as possible. Now it is more about expanding availability to people who couldnt make it to our larger vaccination site. We are trying to make access as easy as possible for those who are interested in being vaccinated, said Jay Reynolds, MD, senior physician executive at Northern Light AR Gould Hospital.

More articles from the BDN

See more here:

AR Gould Hospital expands COVID-19 vaccine opportunities to more locations and broader hours - Bangor Daily News

A number of Brazilian states can now import and use Sputnik V, the Russian vaccine for COVID-19, although a key regulatory agency in the country still has safety concerns.

By Sofia MoutinhoJun. 9, 2021 , 12:50 PM

Sciences COVID-19 reporting is supported by the Heising-Simons Foundation.

Despite safety concerns, the Brazilian Health Regulatory Agency (Anvisa) reversed itself last week and voted to allow a trickle of Sputnik V, the Russian-made COVID-19 vaccine, into the country. Only 928,000 doses will be importedjust a fraction of the total requested by a group of state governorsand the agency imposed stringent measures to reduce supposed health risks and monitor the vaccines safety and efficacy.

In April, with Brazil facing a massive COVID-19 surge and a scarcity of vaccine, Anvisa vetoed a previous import request, citing concerns that the vaccine contains adenoviruses that could replicate and harm vaccinated people. The decision sparked a lawsuit threat by Sputnik Vs manufacturer, the Gamaleya Research Institute of Epidemiology and Microbiology, and drew criticism from some scientists. But on 4 June, four of Anvisas five directors decided to allow the importation of Sputnik V, swayed by a new law and Brazils continuing, worsening crisis. The health context that our country is going through makes us face the need to make the greatest number of vaccines and medicines available, said Alex Machado, one of the four directors. Brazil has one of the worlds highest burdens of COVID-19 but has only vaccinatedabout 15% of its people with a first dose.

Sputnik Vs two doses use two different adenoviruses to deliver genes encoding the spike protein in the pandemic coronavirus SARS-CoV-2. The adenoviruses are supposed to be unable to make copies of themselves. But Anvisas general manager of medicines and biological products, Gustavo Mendes, says the latest documents the agency received, describing analyses performed by the Russian health minister, put the number of replication-competent adenoviruses at not more than 50 per dose. Thats fewer than earlier documentation suggested, but still not acceptable, he adds. It is not clear for us what was the rationale used to approve this specification nor how the presence of these viruses can be safe.

Some scientists outside the fray have previously said Anvisa is misreading such Russian documentation. They argue it does not indicate the presence of live virus, but rather the detection limits of tests for such virus.

According to a Brazilian law enacted in March, the country can selectively import vaccines already approved for emergency use by certain countriesincluding Russia. So Anvisa staffers and the governors had several meetings to discuss ways to get out the shots and, at the same time, minimize risks associated with the vaccine, Mendes says.

Anvisa has for now restricted Sputnik V imports to a number sufficient to cover only 1% of the population of the six northern states that filed the original vaccine request, which called for 67 million doses. The batches will have to undergo analysis by a state-owned lab to show they are safe and do not contain replicant adenoviruses, and only healthy adults will be eligible for the shots.

Moreover, the states administering the vaccine must disclose to the population that the regulatory agency did not clear the products for quality, safety, or efficacy. And in a step proposed by the Brazilian governors, the states will have to conduct a Sputnik V efficacy study under Anvisas supervision.

It was a victory for us, and we are going to work together to follow all the conditions, says Sergio Rezende, Brazils former science minister, who is part of the scientific board supporting the governors who requested the vaccine. Rezende maintains that Anvisa originally vetoed the import for political reasons, as Brazilian President Jair Bolsonaro has criticized COVID-19 vaccines, especially those manufactured by communist countries,such as China and Russia.

Sputnik Vs temporary use permit can be suspended at any time if either Anvisa or the World Health Organization denies it a formal emergency use authorization (still under evaluation in Brazil), or if any issues arise during the laboratory tests or vaccination. There is no prediction of when the approved doses will arrive, but Brazilian governors, Anvisa, and the manufacturer are already discussing the vaccination rollout.

For the immunologist Jorge Kalil, a vaccine expert at the Federal University of So Paulos main campus, Anvisas compromise was a clever strategy. We are not in a position to discard vaccines, and that was a good solution to see if, effectively, under Brazilian eyes, this vaccine works well and can be distributed to the whole population.

See the original post:

Brazil gives Russian COVID-19 vaccine a chance, approving the import of limited doses - Science Magazine

India has partly or fully vaccinated about 101 million men, nearly 17% more than women. Men account for 54% of the total number of people inoculated, according to the data.

Many federally administered regions, the capital Delhi, and big states such as Uttar Pradesh have seen some of the worst inequities. Only Kerala in the south and Chhattisgarh in central India have vaccinated more women than men.

"We are noticing that men, especially in towns and villages, prefer to take the vaccine before women as they have to travel for work, while women are relegated to domestic chores," said Prashant Pandya, medical superintendent at a big government hospital in the western state of Gujarat.

Health officials say rumors about vaccines disrupting women's menstruation cycle and reducing fertility have also contributed to the skewed data. The government has rejected the concerns.

"The government will have to ramp up awareness programs in rural India to ensure women understand the importance of vaccines and prioritize themselves in this race to secure the two shots," said Sudha Narayanan, a former bureaucrat who worked in the health ministry in New Delhi.

Women will have to step forward to get vaccinated or the divide will rapidly widen, Narayanan added.

India, with a population of 1.3 billion, has about 6% more men than women.

A spokesperson for the federal Ministry of Health and Family Welfare did not respond to Reuters' questions about the gender disparity.

Some women in the rural parts of Gujarat and neighboring Rajasthan state have urged the authorities to deliver vaccines at their doorstep, saying they are unable to travel to hospitals leaving their children behind.

"I don't know how to read and write ... how will I register for the vaccine?" said Laxmiben Suthar, a mother of four in the town of Vadnagar in Gujarat. "The government must send the medicine to us."

Urban Indians are also getting Covid shots much faster than the hundreds of millions of people living in the countryside, government data has shown. That is partly due to a policy that helped richer cities buy more vaccine doses than rural districts.

On Monday, Prime Minister Narendra Modi reversed the previous policy and said vaccines will be offered at no charge to all adults starting June 21. The government will also facilitate more walk-in inoculations after complaints about the online registration process.

India has so far administered 233.7 million doses, the most in the world after China and the United States, but given the necessary two doses to only about 5% of its estimated 950 million adults.

See the original post here:

Women are falling behind in India's Covid-19 vaccination drive - CNN

Spain's players and coaches were given COVID-19 vaccinations on Friday morning, three days before their Euro 2020 Group E opener against Sweden in Seville.

The army arrived at the national team's headquarters in Las Rozas, Madrid, to administer different vaccines "depending on the situation of each member."

The Spanish Football Association (RFEF) opted for those members that have not had COVID-19 to be given the single dose of the vaccine to avoid needing a second jab during the competition.

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"I don't want any adverse effects of the vaccine to affect the players during the tournament," Spain coach Luis Enrique said earlier this week.

"We would have liked to have been vaccinated at the right time, which was after the squad list was announced [on June 1]."

Team captain Sergio Busquets' positive test on June 6, followed days later by that of Leeds defender Diego Llorente, disrupted the team's preparations and brought a sense of urgency to have the players vaccinated ahead of Euro 2020.

Llorente has since had three PCR negative tests and needs one more negative result -- which he returned on Friday, thus allowing him to rejoin the team.

The RFEF said in a statement it was "grateful and thankful" to the Spanish authorities for "their sensibility" when giving the approval.

The vaccination of the players has been a source of controversy for weeks.

Only 25% of Spain's population has been fully vaccinated, with no date scheduled for when those under 40 will be vaccinated.

The Spanish government ultimately authorised priority vaccinations for the footballers on Thursday.

Some local politicians have said it is "deplorable" that Luis Enrique's team is getting preferential treatment over essential service workers, such as shop attendants, delivery drivers, with one politician stating "those that were at the forefront of the pandemic have been relegated by 11 men tapping a football."

Moreover, others are questioning if it's worth vaccinating the players three days before the start of the tournament, when the vaccine will only become effective two weeks after it is administered.

Aside from Busquets, eight players -- Jose Gaya, Mikel Oyarzabal, Thiago Alcantara, Adama Traore, Aymeric Laporte, Eric Garcia, Fabian Ruiz and Ferran Torres -- in Spain's squad have tested positive for COVID-19 since the start of the pandemic.

Liverpool midfielder Thiago, who tested positive for COVID-19 in September, said: "We are fortunate to have access to it. We have less risk in our profession, but we need to be thankful to those that have wanted to help us.

"The vaccine is a priority in the world. We are representing Spain, hopefully in different countries, [if they go beyond the group stages], and if we are vaccinated, all the better."

Spain's Olympic athletes have been receiving the vaccine since May 17.

Spain's Olympic Committee announced that 3,880 doses -- the amount used to vaccinate the Spanish Olympic and Paralympic athletes -- will be given to the Spanish government thanks to a donation by American company Pfizer.

Due to the pandemic, UEFA expanded squad limits from 23 to 26 players for Euro 2020, which is taking place a year later than scheduled.

Luis Enrique only selected 24 players, however, and has faced criticism because of it.

He has stood by the decision despite having to form a parallel training bubble with other players in case he had to make changes to the squad.

Spain will host their Group E games against Sweden, Poland and Slovakia in Seville's La Cartuja stadium.

See original here:

COVID-19: Spain players, coaches vaccinated by army ahead of Euro 2020 opener - ESPN