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J&J vaccine pause brings challenges for US college students

Science
56 min ago

J&J vaccine pause brings challenges for US college students

From CNN’s Jacqueline Howard

A dose of the Johnson & Johnson coronavirus (COVID-19) vaccine is seen on a table at a Northwell Health pop-up coronavirus vaccination site in Staten Island on April 08, 2021 in New York City.  Michael M. Santiago/Getty Images

In the wake of the Johnson & Johnson vaccine pause, many colleges and universities that intended to administer the single-dose vaccine to their students have pivoted their plans to use the two-dose Pfizer/BioNTech or Moderna vaccines instead – but it comes with some hurdles. 

The new approach has the challenge of ensuring that students receive their second dose of vaccine, which likely will be administered off campus since the current school year is soon ending, Dr. Oscar Alleyne, chief of programs and services for the National Association of County and City Health Officials, told CNN on Wednesday. 

“The decision is going to be that schools still will provide their first dose, and of course the students then leave to go home, and they will receive their second dose at their home location,” Alleyne said, adding that there is some expected difficulty in vaccination sites being able to communicate who has received a dose and who hasn’t.

“It’s not necessarily contiguous,” Alleyne said. “You may be vaccinated here but a local site in another jurisdiction may not have access to that information, so it’s just reconciling how that logistically would be done.”

2 hr 6 min ago

Turkey reports fourth consecutive day of record Covid-19 deaths

From CNN’s Gul Tuysuz in Istanbul

Turkey announced at least 362 new Covid-19 deaths on Wednesday, hitting a record high for a fourth consecutive day. 

There were 61,967 daily Covid-19 cases, according to the Turkish health ministry pandemic dashboard. 

The country has administered a total of 20,586,650 doses of coronavirus vaccines since the start of its campaign in January, according to the health ministry dashboard. At least 7,903,495 people have received both doses, according to the ministry.  

Turkey went into partial lockdown last week at the start of the Muslim holy month of Ramadan after daily cases and deaths hit record highs.  

2 hr 7 min ago

Greece will start gradually easing Covid-19 restrictions next month

From CNN’s Chris Liakos in London

Greek Prime minister Kyriakos Mitsotakis in Athens on April 14, 2021. Louisa Gouliamaki/AFP/Getty Images

Greece will gradually begin easing Covid-19 restrictions starting next month, but only after the Greek Orthodox Easter, Prime Minister Kyriakos Mitsotakis said in a televised address on Wednesday.  

According to the government’s roadmap, cafes, bars and restaurants will be able to reopen on May 3, operating outdoor service only.  

Primary and secondary schools will follow a week later on May 10, and from May 15, the ban on movement between regions will be lifted to coincide with the official opening of the tourism season.

Earlier this week, Greece lifted quarantine requirements for vaccinated travelers and those testing negative from key tourism markets — the European Union, the UK, the US, Israel, Serbia and the UAE. Visitors are subject to current domestic restrictions. 

Mitsotakis said that a ban on movement will remain in place during Greek Orthodox Easter observances next week in order to achieve a “safe Easter” and a subsequent “free summer”.

Mitsotakis said that the pandemic situation in the country is stabilizing and reiterated the importance of the vaccine rollout, adding that starting next week people over 30 years old will be eligible to get vaccinated in an effort to speed up the process.

Greece on Wednesday recorded 3,015 cases and 86 new deaths. The country has recorded 323,639 Covid-19 cases since the start of the pandemic, and 9,713 deaths. The number of people in intensive care units remains very high.

2 hr 49 min ago

Brazil has the highest overall Covid-19 death rate in Southern Hemisphere

From CNN’s Hira Humayun

Workers in protective gear as a preventive measure against the spread of the novel coronavirus disease bury coffins at the Vila Formosa cemetery in Sao Paulo, Brazil, on April 17, 2021. Miguel Schincariol/AFP/Getty Images

Brazil has the highest Covid-19 death rate in the Southern Hemisphere and the Americas according to data tracked by CNN, as of Wednesday.

According to number of Covid-19 deaths from Johns Hopkins University, and population numbers from the UN and World Bank, Brazil is ahead of Peru, the United States and Mexico in terms of deaths per 100,000 people.

At Wednesdays Pan American Health Organization (PAHO) briefing, Director Dr. Carissa Etienne said, “After a difficult few months, Brazil is reporting a drop in cases including in the amazon region; but cases remain alarming high across Brazil and certain municipalities have been quick to ease restrictions, so it is very likely that these trends will reverse.”

1 hr 26 min ago

Germany’s lower house votes to allow federal govt Covid-19 lockdown powers

From Colin Ivory Meyer in Berlin and Stephanie Halasz in London

Protesters gathered outside the Reichstag on April 16, 2021 where the Bundestag was in session for the first reading of new measures to rein in the spread of the coronavirus, in Berlin, Germany. Sean Gallup/Getty Images

Germany’s parliament, the Bundestag, has voted in favor of an amendment to the Infection Protection Act on Wednesday, which would allow the federal government to impose nationwide lockdown measures against Covid-19.

In a roll call vote, 342 voted for the bill, 250 opposed and 64 abstained, according to the parliament website.

If the bill passes the Parliament’s upper house on Thursday, the government will be empowered to enact an “emergency break” lockdown which would trigger nightly curfews in some areas with high infection rates from 10 p.m. to 5 a.m. local time (CET) with the exception that people can be outside until midnight if they are out alone. The bill also calls for strict regulations of schools in regards to in-person and online learning.

Up until now, Germany’s 16 states held the balance of power to self-determine their own Covid-19 measures. But the federal government sought a more unified approach to battle continuing Covid-19 infections amid a slower-then-hoped for vaccination rollout. 

There has been widespread criticism in the lead-up to the vote with members of the public and the political opposition questioning if a coherent federal approach to the Covid-19 crisis was compatible with Germany’s constitution.

Hundreds have been protesting across Berlin Wednesday against allowing the federal government greater powers, live pictures showed. There were violent clashes with the police and 152 protestors have been arrested, according to Berlin police.

If the bill passes Germany’s upper house, the amendment becomes law, and the changes could go into effect as early as Friday.

3 hr 21 min ago

FDA’s pause on J&J vaccine after inspection means the process is working, official says

From CNN’s Betsy Klein

Doses of the Johnson & Johnson Covid-19 vaccine in Orlando on April 10. Paul Hennessy/SOPA Images/LightRocket/Getty Images

A senior administration official said Wednesday that the US Food and Drug Administration’s announcement indicates that the process “is working as it should.” The FDA said this morning that the Emergent facility inspection is complete and vaccine production remains on hold due to potential quality issues.  

“From our perspective, the FDA has a job to do, which is to make sure that every vaccine that is released in the country is safe and effective,” the official said, adding, “That’s a process that is working as it should. It’s important for Americans to know that no vaccines have been released from that plant, and they only will be when the FDA authorizes it.”

Citing Pfizer and Moderna vaccine supply, the official said that Emergent’s continued closure will not impact the administration’s commitments to getting shots in arms.

“Our concern right now is not to try to rush anything, because we’re just not affected. The President’s commitments, obviously, the 200 million vaccinations wasn’t dependent on this. His commitment that we will have enough vaccines for all the adults who want them by the end of May is not affected by this. And so we will just let that play itself out. But the American public has two highly effective, very safe vaccines,” the official said.

3 hr 37 min ago

Breakthrough Covid-19 infections “rare” among fully vaccinated nursing home residents, CDC says

From CNN’s Jen Christensen

Most fully vaccinated residents of nursing homes were not infected, even after someone in the same facility tested positive for Covid-19, according to a new study that looked at infections in nursing homes in Chicago from the US Centers for Disease Control and Prevention. 

Among the nearly 8,000 residents and nearly 7,000 staff that have received two doses of a Covid-19 vaccine since December, there were only 22 breakthrough infections among the fully vaccinated, according to the CDC’s Weekly Morbidity and Mortality Report published on Wednesday. 

The CDC considers people to be fully vaccinated two weeks after the second dose of the Pfizer or Moderna vaccine or two weeks after the single Johnson & Johnson vaccine.

Of the 22 breakthrough cases, there were 12 residents and 10 staff members who tested positive for Covid-19 after being fully vaccinated. Two-thirds of those who tested positive, 14 people, were asymptomatic. Two residents were hospitalized and one of those residents died, the CDC said. The person who died had three underlying conditions, according to the CDC.

There was no facility-associated secondary transmission. 

Although they are rare, the CDC said breakthrough infections can happen because no Covid-19 vaccine provides 100% protection. While some earlier studies suggested that the vaccines provide total protection against severe illness and death, data on vaccination and transmission in congregate settings like nursing homes has been limited.

Some context: The CDC said that this study confirms how important it is for people to get vaccinated, particularly in congregate settings where it is difficult to keep physical distance.

The study also shows that nursing homes still need to follow recommended infection and control practices. Residents who get Covid-19 still need to be isolated from others and residents that have had close contact with them should be quarantined. Nursing homes should continue regular testing and staff should continue to wear PPE, regardless of vaccination status. 

“Maintaining high vaccination coverage among residents and staff members is also important to reduce opportunities for transmission within facilities and exposure among persons who might not have achieved protective immunity after vaccination,” the report concluded. 

4 hr 3 min ago

CDC projects up to 596,000 US Covid-19 deaths by May 15

From CNN’s Ben Tinker

An ensemble forecast published Wednesday by the US Centers for Disease Control and Prevention now projects there will be 579,000 to 596,000 coronavirus deaths in the United States by May 15.

“This week’s national ensemble predicts that the number of newly reported COVID-19 deaths will remain stable or have an uncertain trend over the next 4 weeks,” CDC said.

The previous ensemble forecast, published on April 14, projected up to 598,000 coronavirus deaths by May 8.

At least 568,532 people have already died from Covid-19 in the United States, according to data compiled by Johns Hopkins University.

3 hr 37 min ago

FDA completes facility inspection, J&J vaccine production remains on hold

From CNN’s Jacqueline Howard and Jamie Gumbrecht

The Emergent BioSolutions facility in Baltimore on April 1. Tasos Katopodis/Getty Images

The US Food and Drug Administration announced on Wednesday that it recently completed an inspection of the Emergent BioSolutions facility in Baltimore – which makes the drug substance that goes into Johnson & Johnson’s coronavirus vaccine. New production is still paused while FDA and Emergent work through several potential quality issues.

The FDA’s inspection ended Tuesday and “cited a number of observations concerning whether the facility’s processes met our requirements and standards,” Dr. Janet Woodcock, acting FDA commissioner, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement released on Wednesday.

They emphasized no products will be released before meeting the FDA’s quality standards.

The FDA report says Emergent has not thoroughly investigated cross-contamination of a viral vaccine drug substance batch, and the investigation did not include a thorough review of how people moved in and around the facility as a potential source of contamination. 

“There is no assurance that other batches have not been subject to cross-contamination,” the report says.

The report also says, based on security camera footage and direct observation, written procedures to prevent cross-contamination “are not followed” during production and not documented. Components and product containers were not handled or store in a way to prevent contamination, the report says; written procedures to assure drug substances are manufactured at the appropriate quality, strength and purity “are inadequate”; and employees weren’t adequately trained.

The building used to manufacture the vaccine drug substance wasn’t a suitable size or design to facilitate cleaning and proper operations, and equipment used “is not of adequate size” to operate as intended,” the report says.

Additionally, the FDA’s inspection document notes peeling paint, unsealed bags of medical waste, residue on walls and damaged floors and rough surfaces that “do not allow for adequate cleaning and sanitization.” 

 In a statement, Emergent said it is “committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified.”