Covid-19 vaccine

Vial and syringe with a vaccine

Clover Biopharmaceuticals, a clinical-stage firm developing a Covid-19 vaccine with potential manufacturing and distribution advantages over other vaccine technologies, has raised $230 million as it prepares to advance its lead candidate into pivotal testing.

Chengdu, China-based Clover said Tuesday that it expects to start a global Phase 2/3 clinical trial for its vaccine candidate, SCB-2019, in the first half of this year. The company added that it has already started planning for the production of potentially hundreds of millions of vaccine doses.

The Clover Covid-19 vaccine is protein-based. SARS-CoV-2, the virus that causes Covid-19 infection, is an enveloped RNA virus—the outer coating is dotted with spike proteins that bind to a receptor on the host cell. These spikes are trimeric, meaning they’re formed by three proteins.

Using its Trimer-Tag technology, Clover developed a trimeric spike protein that resembles the one found on the outer envelope of the novel coronavirus. The vaccine uses an adjuvant, an ingredient that boosts immune response, supplied by Dynavax Technologies.

As a protein-based vaccine similar to many of the vaccines developed for influenza, shingles, and hepatitis B, Clover said production can use manufacturing processes that are already well established. The company added that this production can be rapidly scaled up to large quantities.

Another advantage of the Clover vaccines are the temperature requirements. The company said its vaccines and adjuvant should be stable for long periods at refrigerator temperatures of 2 to 8 degrees Celsius. At room temperature, Clover has said its vaccines are stable for at least two months. Those temperature and storage requirements stand in contrast to messenger RNA vaccines, which must be distributed frozen and stored at temperatures well below what medical-grade freezers can achieve. Last week, Pfizer and BioNTech asked the FDA to approve a change in the storage temperatures permitted once vaccines reach a vaccination site.

The new financing follows publication in The Lancet earlier this month of peer-reviewed results from an early-stage test of two Clover Covid-19 vaccine candidates. The 150-patient study showed that the vaccines were well tolerated and safe. Both vaccines also induced neutralizing antibodies at levels comparable to or higher than those found in the blood of those who have recovered from Covid-19.

Clover said that its research includes vaccines that could address multiple variants of the novel coronavirus. In addition to supporting its Covid-19 vaccines, Clover said the new capital will support plans to advance multiple programs into human testing later this year. Other vaccines in the Clover pipeline include programs for rabies and influenza. The company also said it plans to expand its manufacturing and capabilities.

GL Ventures and Temasek both led the Series C financing. Oceeanpine Capital, OrbiMed, and Delos Capital also invested. Clover said it has raised more than $400 million in the past year.

Clover also has financial support from the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed to finance development of the company’s Covid-19 vaccine candidate up through licensure with a total investment of $328 million. Some of that cash will fund the global Phase 2/3 study. If the Clover vaccine is shown to be safe and effective, it would be distributed through Covid-19 Vaccines Global Access, or COVAX, the World Health Organization’s initiative to ensure equitable vaccine access throughout the world.

Public domain photo by Flickr user Alachua County

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As 2021 dawned and vaccine distribution has picked up, many people had one overarching question on their minds: how and when will they get vaccinated.

At the same time, providers have had to grapple with another question:  how to best approach for this historic, monumental task.

For Stamford Health in Connecticut, the way forward was clear: Leverage existing partnerships with the city of Stamford, community organizations and the state to distribute the much-anticipated vaccines.

The health system has been sharing data and information with the city of Stamford throughout the pandemic, including positivity rates, hospitalizations and other key metrics, said Kathleen Silard, CEO of Stamford Health, in a phone interview. Stamford Health and the city worked collaboratively to set up testing sites, and in the last few months, they also worked together to set up vaccination sites — including one at an old hospital on Stamford Health’s campus.

“The collaboration [with the city] really is to pool our resources, because we know, together we are better,” Silard said.

The health system began vaccinating healthcare workers, first responders and other eligible essential workers on Dec. 17, when the state was in Phase 1a of its vaccine rollout. Back on Jan. 18, it began vaccinating people older than 75 and recently added those older than 65 to the list, as part of Phase 1b of the rollout.

So far, the health system has administered around 27,000 vaccines, and is averaging between 750 and 930 doses a day, Silard said. But Stamford Health has ambitious plans to increase this number three-fold.

The health system is planning to open a new, much larger, site around March 1, which will enable the provider to administer up to 3,000 doses a day, she said.

But getting shots in people’s arms is not without its challenges.

Vaccine availability has been one of the biggest hurdles the health system has faced, but working closely with Connecticut Gov. Ned Lamont and his team has helped the system get the doses and resources it needs, Silard said.

Aside from uncertainty with vaccine availability that has since receded into the background, Stamford Health is tackling a more intractable problem: vaccine hesitancy and health inequity. Both present a formidable barrier to its 3,000-a-day vaccination goal.

To help combat vaccine hesitancy, Stamford Health is conducting outreach programs, including setting up panels with people who have already received the vaccine to talk about their experience, Silard said. The system is also participating in Stamford Mayor David Martin’s weekly Zoom calls to further educate the public on the vaccine.

The Covid-19 pandemic shone a harsh light on existing health disparities in the country, with people in minority racial groups and low-income populations most likely to get the disease and die from it.

Stamford Health has put together a task force, which includes health system members, city officials and members of community health organization Vita, to ensure that vaccines are being administered in an equitable manner, said Silard.

In addition, the health system is partnering closely with the National Association for the Advancement of Colored People and Building One Community, an organization that works with the undocumented community, to focus vaccine administration efforts on underserved populations.

Building One Community has developed a great deal of trust with a population that is typically hesitant to use healthcare services, said Dr. Anka Badurina, executive director of the organization, in a phone interview.

Through the pandemic, the organization has been working to ensure immigrant and underserved communities are included in response efforts — from testing to, now, vaccination.

One of its main areas of focus has been helping the elderly in these communities get registered for vaccine appointments, Badurina said. Those currently eligible often don’t have access to the internet or an email address, which is typically required for registration. Building One Community, which has interpreters on hand, helps them with the process.

Further, the organization helps organize transport to vaccination sites.

“Stamford Health partners with organizations like Building One Community [because] you have to go to those that have a trusted voice in the community,” Badurina said. “They are the ones that know where the community is and know exactly what the community is lacking.”

With the help of its community partners Stamford Health has established a “No Barriers” day, where members from minority groups and under-resourced communities can come to a vaccination site without an appointment, get registered and get vaccinated, Silard said. No individuals are asked about their immigration status or other questions that might keep people from coming to get vaccinated.

Stamford Health wants to eliminate any traditional barriers to vaccination to ensure that the largest swath of eligible individuals can get vaccinated, Silard said.

“We see [vaccine administration] as our moral, ethical responsibility to help fight this deadly disease,” she said.

Photo: LarisaBozhikova, Getty Images

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Monday, 22 February, marks the official start date of the COVID-19 vaccine rollout in Australia as more than 142,000 Pfizer vaccines touched down at Sydney Airport – an endeavour that has been dubbed Australia’s biggest peacetime operation.

The shipment, delivered by Singapore Airlines cargo, is the first of 20 million doses that the Government has secured as part of the COVID-19 Vaccine and Treatment Strategy.

“It was March the 11th last year that the pandemic was declared and now on Aussie soil we have the Pfizer vaccine and it’s ready to go,” Pfizer’s Medical Director Krishan Thiru told the Today show this morning.

“Our focus is on delivering the vaccine to the points of use where the Government asks us to deliver them. That’s what we’re focused on and that’s what we’ll do.”

The vaccine rollout is due to begin next week with the first Australians to begin receiving the vaccine from 22 February.

“The vaccine has landed and we’re stepping up our fight against the pandemic,” Prime Minister Scott Morrison said.

“Once the final safety checks are completed we can start rolling out the vaccine to our most vulnerable Australians and to our frontline border and health workers.

“The hard work of Australians has meant we’re in an enviable position in our fight against the pandemic, so we’ve been able to take the time to properly assess our vaccine decisions and give our world-class regulator the time they need to review the safety of the jabs.

“While we’re taking the time to get the rollout right, I am confident all Australians who wish to be vaccinated against COVID-19 will receive a vaccine this year.”

Who gets first dibs on the vaccine?

As part of the ‘Phase 1a’ vaccine rollout, 80,000 doses will be administered in the first week. 50,000 doses have been allocated to quarantine and border workers and frontline healthcare workers, while 30,000 are reserved for aged care and disability care staff and residents. 62,000 will be set aside for second doses which will be given 21 days after the first dose.

Supplied: Australian Government

The Government’s goal is to eventually deliver 150,000 jabs per day and have the entire adult population vaccinated by late October.

The vaccine will be administered in hospital ‘hubs’ across Australia as well as in residential aged care and disability facilities.

How will the vaccine be stored?

Logistics company DHL has stepped in to tackle the complex task of getting the vaccine to Australians around the country.

The company will employ a network of 200 portable ultra-low-temperature freezers to ensure the vaccine, which needs to be stored at minus 70 degrees, can be delivered safely.

Dr Thiru said the vaccines had been shipped to Australia on specially-designed thermal shippers and were kept in refrigerated containers.

“Our company has a rich heritage in cold chain vaccine storage and distribution. We’ve so far got a 99.9% success rate from delivering the vaccines from the factory door to where they’re used with the quality and integrity interact,” he said.

Will the vaccine stop virus transmission?

Although the vaccine is designed to protect against COVID-19 and its variants, it is too early to tell if it will stop the transmission of the virus.

“You’d need to see a larger proportion of the population vaccinated before you can tell whether it’s going to stop transmission or not and whether you’re going to see a downturn in the rates,” Dr Thiru said.

He explained that laboratory testing results were promising and indicated that the vaccine could be effective against some of the newer COVID-19 strains including the UK, South African, and Brazilian variants.

“If sometime in the future it becomes apparent it’s not effective, you can easily tweak the formula for the vaccine.”

Why has the vaccine rollout taken so long?

When asked why Australia has been slower than other countries in the vaccination rollout, Dr Thiru explained that “every country’s situation is different.” A vaccine, he said, could not start production until it was given the go-ahead by certain authorities.

“Vaccinations can’t start until the vaccine has been fully and thoroughly evaluated by the independent regulatory agency and approved,” he said.

“The TGA is one of the world’s most respected agencies. They get a full evaluation.

“They didn’t have that emergency situation we’ve seen in some other countries.”

The Therapeutic Goods Administration (TGA) is conducting batch tests on the first of the Pfizer vaccine arrivals to ensure they meet quality standards before they are deployed next week.

“Australians can be reassured this vaccine has gone through rigorous, independent testing by the Therapeutic Goods Administration to ensure it is safe, effective, and manufactured to a high standard,” Minister for Health and Aged Care Greg Hunt said.

“These vaccines will now go through further batch testing to further check for quality and efficacy, ensuring all Australians have confidence in the vaccines they receive.”

Why did Pfizer get first preference?

The Pfizer/BioNTech vaccine is the first to be provisionally approved for use in Australia by the TGA with a 95% efficacy score from a clinical trial last year.

Despite the promising results, there have been ongoing concerns over the vaccine’s safety and effectiveness.

33 Norwegian officials aged 75 and older died a short time after receiving the Pfizer vaccine in mid-January and other countries have since reported further deaths and side effects.

A World Health Organization (WHO) committee said this was “in line with the expected, all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals” and that the risk-benefit balance of the vaccine “remains favourable in the elderly.”

The TGA said that, although no concrete link has been established between the deaths and the vaccine, it would work with international authorities and Pfizer to get more information.

Chief Medical Officer Dr Brendan Murphy told Nine News that he was not unduly concerned about the Pfizer vaccine rollout, which he says is part of a “diversified vaccine strategy.”

“That’s why we’ve bought more than one vaccine and I still think the Pfizer vaccine will be okay but we just have to wait and see,” he said.

In addition to the Pfizer vaccine, Australia has approved 53.8 million AstraZeneca vaccine doses and 51 million Novavax vaccine doses.

The Government has also signed up to the international COVAX Facility which provides access to a range of vaccines to immunise up to 50 per cent of the Australian population.

The full press release for the vaccine rollout can be found here.

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A major hurdle to quick and efficient vaccine distribution could be the proliferation of “pharmacy deserts” across the country.

There are 56,802 local and chain pharmacies, which evens out to about 1.83 pharmacies per 10,000 people on average, according to a new report from GoodRx. But these facilities are unevenly distributed leaving many residents in “pharmacy deserts.” These are areas where people have to drive a long distance to reach the closest pharmacy or areas with too many people sharing the same pharmacy.

Pharmacy deserts may have dire implications for the Covid-19 vaccine rollout, according to a report from GoodRx, which tracks U.S. prescription drug prices and provides free discount coupons. Since pharmacies are playing a key role in administering the vaccine, living in a pharmacy desert may prevent Americans from getting vaccinated in a timely manner.

Two vaccines have been approved in the U.S., one developed by Pfizer and BioNTech, and the other by Moderna. Both are two-dose vaccines. So far, the rollout has been characterized by missteps and is moving slowly, with only 17 million vaccine doses administered out of nearly 38 million distributed as of Thursday, according to data from the Centers for Disease Prevention and Control. But President Joe Biden has promised to speed up the process — vowing to administer 100 million Covid-19 vaccine shots in the first 100 days of his administration.

GoodRx examined pharmacy deserts using information from the National Council for Prescription Drug Program’s DataQ and the GoodRx databases. Researchers also used data from the American Community Survey to calculate population per county.

Both rural and urban areas can have pharmacy deserts, according to the report.

Pharmacy deserts in rural counties are more likely to be characterized by a lack of pharmacy resources. About 177 U.S. counties have zero pharmacies, leaving 635,000 residents with no choice but to drive a long distance to access one.

On the other hand, pharmacy density is a bigger issue for Urban Americans, the report shows. For example, there are 10 million people living in Los Angeles County in California, but there are only 1.61 pharmacies per 10,000 residents. Cook County in Illinois, which has 5.2 million residents, has only 1.50 pharmacies per 10,000 residents. Both fall below the national average of 1.83 pharmacies per 10,000 residents.

Many pharmacy deserts are also vaccination deserts, the report states.

For instance, assuming the promised 100 million vaccines are distributed, only 11.2% of the population in San Mateo County, California, will receive both doses of the Covid-19 vaccine, researchers estimate, as the county only has 1.06 pharmacies per 10,000 residents.

Other similar vaccine deserts include Shelby County, Tennessee, El Paso County, Texas and Pinal County, Arizona.

The researchers conclude that administering the Covid-19 vaccine through pharmacies alone “is not going to cut it.” Additional mass vaccination sites are going to be needed as well as support services in more rural counties, like transportation or in-home vaccinations.

Biden’s administration has already heeded the call for more vaccination sites. The president’s vaccine distribution plan, unveiled in a speech last week, includes plans to mobilize the Federal Emergency Management Agency and the National Guard to ramp up distribution, according to STAT News.

Photo: LarisaBozhikova, Getty Images

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Though doses of the long-awaited Covid-19 vaccine are making their way around the country, the rollout is moving slowly and there have been countless reports of doses being thrown away in situations that could have been avoided, including labeling errors. Now, states such as New York, California and Florida, are threatening to penalize providers that are not efficiently and appropriately distributing vaccine doses.

More than 15 million doses of the vaccine have been distributed across the country so far, but only about 4.5 million people have received their first dose, data from the Centers for Disease Control and Prevention shows.

In New York, 274,713 people have received the first dose of the vaccine out of the 895,925 doses distributed to the state. This represents a vaccination rate of 1,412 per 100,000 people, according to the data.

On Sunday, New York State Health Commissioner Dr. Howard Zucker issued a letter to vaccine providers outlining expectations for distribution, including requiring that all vaccine doses in the providers’ inventory prior to Jan. 4 be administered to eligible recipients by Jan. 7.

“Any doses that are not administered by end of day on January 7 will be redistributed to another facility and future allocations to such facilities will be limited, and possibly eliminated,” the letter reads.

At a news conference Monday, New York Gov. Andrew Cuomo said that going forward, facilities in the state must administer their entire vaccine allotment within seven days of receiving it or risk facing a fine of up to $100,000.

In addition, providers “who do not comply or are found to be seriously deficient” may incur more serious sanctions and fines, including being disqualified from future vaccine distribution.

Florida Gov. Ron DeSantis made similar remarks at a press conference Monday, stating that “hospitals that do not do a good job of getting the vaccine out will have their allocations transferred to hospitals that are doing a good job in getting the vaccine out.”

Though he did not threaten to levy fines, DeSantis said that hospitals have been asked to submit their vaccine distribution plans to the state.

“We do not want a vaccine to just be idle at some hospital system,” he said.

Florida’s vaccination rate is similar to New York’s at 1,232 per 100,000 people. The state received 1.13 million doses of the vaccine, but only 264,512 Floridians have gotten their first dose, CDC data shows.

In California — where the current Covid-19 vaccination rate is 1,143 per 100,000 people — Gov. Gavin Newsom confirmed that healthcare providers that violate priority guidelines for vaccine distribution will have their licenses revoked.

“I just want to make this crystal clear,” he said at a news conference last week. “If you skip the line or you intend to skip the line, you will be sanctioned, you will lose your license.”

California’s vaccine distribution plan is divided into three phases, beginning with vaccinating healthcare workers and long-term care residents.

The governor’s office plans to work with the California Medical Association to create an enforcement plan “to make sure that someone’s not passing a few vials over to their cousin or aunt or uncle, or God forbid, making a buck or two on the backs of a vaccine that should be distributed to someone who is at high risk or at higher need,” Newsom said.

Photo credit: Pornpak Khunatorn, Getty Images

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A woman dressed in protective gear walks away from a doorway at the Good Samaritan Society nursing home on December 30, in Simla, Colorado. A Colorado National Guard soldier who was deployed at an ongoing Covid outbreak at the nursing home is the first person in the U.S. to have tested positive for a more contagious Covid-19 variant. Photo credit: Michael Ciaglo, Getty Images

As the U.S. passes another grim record for Covid-19 deaths, a new strain of the novel coronavirus thought to be more transmissible has been identified in two states. The B.1.1.7 variant, first identified in the United Kingdom in September, was detected in a small town in Eastern Colorado and in San Diego this week.

The new strain of SARS-Cov-2 is thought to be 50% to 70% more transmissible, thought not necessarily more deadly. The concern is that it could drive more community spread, which could result in more hospital and ICU beds being filled, said the Colorado Department of Public Health and Environment’s Chief Medical Officer, Dr. Eric France.

“We need to be aggressive with vaccination. It appears this vaccine we estimate will be just as effective with the new variant as it was with the old,” he said at a Thursday press conference. “If we see cases start to come up, and if our own sequencing finds this has been driven by the variant, we may have to act quicker and more broadly in our thinking.”

One Colorado National Guard member tested positive for the new strain of SARS-Cov-2, and another one is presumed to have it. Both were responding to an outbreak at the Good Samaritan Society nursing home in Simla, Colo., where all 26 of its residents and nearly two-thirds of its staff had tested positive for Covid-19.  The Good Samaritan Society in Simla declined to comment for this article.

According to preliminary testing results, there isn’t any evidence that the B.1.1.7 variant is currently circulating in the nursing home, state epidemiologist Dr. Rachel Herlihy said in a press conference. Most of the cases with the outbreak took place before the two National Guard members arrived on Dec. 23.

“Therefore, we’re also looking into the second possibility, the possibility that exposure happened outside of the Simla facility,” she said.

Neither of them had traveled outside of the U.S., indicating potential community transmission.

Another case of the variant was identified in San Diego, after a man tested positive and results were confirmed at Scripps Research. He, too, had no history of travel outside of the U.S.

“This shouldn’t be a surprise and there are likely more cases than the three we’re talking about,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security who specializes in infectious diseases and pandemic preparedness.

He added that it was more reason to follow public-health guidance, such as wearing masks and social distancing.

“It adds more urgency to the fact if you couple the discovery of the strain with a really lagging vaccination program,” he said in a phone interview.


Slow vaccine rollout

By the end of the year, officials with Operation Warp Speed had hoped 20 million people would receive their first dose of the vaccine. But just 2.79 million people have received their first shot of 12.4 million distributed doses, according to data from the Centers for Disease Control and Prevention.

In long-term care facilities, just 167,149 people have received vaccines of a total of 2.17 million distributed doses, according to the CDC. Retail pharmacies, such as CVS and Walgreens, have been tasked with going into nursing homes and assisted living facilities to distribute the vaccine.

CVS said it expects to vaccinate 4 million residents and Walgreens expects to vaccinate 3 million residents through the program, which began last week. Some facilities, such as Grace Manor Care Center, near Colorado’s border with Kansas, won’t receive their first doses until January 9.

“The individuals who are responsible for the vaccinations right now need more federal support. You need to be able to get our state and local health departments to be able to have the bandwidth to do this,” Adalja said. “These are the same people who have been tasked with responding to increasing numbers of cases, including at the hospital level.”

California is still in the process of vaccinating healthcare workers, as well as paramedics, and workers and residents at long-term care facilities. The state has allocated 1.76 million doses of the vaccine so far.

Colorado has also prioritized healthcare workers and long-term care facilities in its first round of vaccinations. It has administered more than 84,000 doses so far, Gov. Jared Polis said on Thursday.

But this is still the easy part, Adalja said. And healthcare workers that aren’t affiliated with a hospital, such as community mental health workers or private practice physicians, are facing challenges in getting their shot.

“It’s going to be a lot harder when you go to phase 1B, and you’re starting to vaccinate front-line essential workers that are not healthcare workers as well as people who are high risk in the community,” he said. “It’s just much more complicated logistically when you’re talking about a vaccine — suppose you’re using the Pfizer vaccine — that you can’t keep it close to patients because it has such cold storage needs. The Moderna vaccine makes it easier to do that.

“In general, we need to figure out how is this going to happen. Is it going to be drug stores, is it going to be doctor’s offices, are there going to be mass vaccination sites at high schools or stadiums?” Adalja added. “That kind of thing we need to start thinking about because there are a lot of people who need to be vaccinated.”

With the discovery of the new strain, Polis said he had asked the Centers for Medicare and Medicaid Services for permission to pause visits in nursing homes so residents could be vaccinated quickly.

Separately, the state also decided to make the vaccine available to people ages 70 and up in its next round of doses, through local hospitals or community health clinics.

Polis said he expects this process to take four to five weeks, based on projections for how many vaccines Colorado will get in the future. That could be subject to delays, or happen faster, depending on what takes place at the federal level, he said.

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