The mRNA Vaccines Are Looking Better and Better

 

A year ago, when the United States decided to go big on vaccines, it bet on nearly every horse, investing in a spectrum of technologies. The safest bets, in a way, repurposed the technology behind existing vaccines, such as protein-based ones for tetanus or hepatitis B. The medium bets were on vaccines made by Johnson & Johnson and AstraZeneca, which use adenovirus vectors, a technology that had been tested before but not deployed on a large scale. The long shots were based on the use of mRNA, the newest and most unproven technology.

The protein-based vaccines have moved too slowly to matter so far. J&J’s and AstraZeneca’s vaccines are effective at preventing COVID-19—but a small number of recipients have developed a rare type of blood clot that appears to be linked to the adenovirus technology and may ultimately limit those shots’ use.

Meanwhile, with more than 180 million doses administered in the U.S, the mRNA vaccines have proved astonishingly effective and extremely safe. The unusual blood clots have not appeared with Pfizer’s or Moderna’s mRNA technology. A year later, the risky bet definitely looks like a good one.

The U.S. has ordered enough mRNA vaccines to inoculate its entire population. In that context, the CDC and FDA’s call to pause the J&J rollout this week is a blow to the American inoculation campaign, but hardly a devastating one. (J&J’s vaccine accounts for less than 5 percent of doses administered so far, and AstraZeneca’s has not yet been authorized in the U.S.) But the rest of the world has been banking on the J&J and AstraZeneca vaccines, which are both cheaper and easier to distribute because they don’t require the same cold storage as mRNA vaccines.

If the blood-clot risk is real, the divide between the mRNA-vaccine haves and have-nots will only grow. The U.S. will be fine; the rest of the world will face difficult questions about balancing the risks and benefits of an affordable, good-but-not-best vaccine against a disease that has killed nearly 3 million people.

The blood-clot events with the AstraZeneca and J&J vaccines are so rare—appearing in one in 100,000 to one in 1 million vaccine recipients—that they would not have shown up in clinical trials, even ones conducted within more leisurely, non-pandemic timelines. (The COVID-19 vaccine trials, which generally included tens of thousands of participants each, were actually unusually large because researchers wanted data as quickly as possible.)

“It’s true with all new medications of any sort. You only find rare events when things are rolled out to very vast numbers of people,” says John Grabenstein, the associate director of scientific communication for the Immunization Action Coalition, who used to work on vaccines for the pharmaceutical giant Merck. “One-in-a-million events are just barely measurable.” That faint signal is especially difficult to see against a noisy background: Some people get blood clots for reasons unrelated to the vaccine, too.

In Europe, the strange nature of these blood clots tipped doctors off to a possible link to AstraZeneca’s vaccine. The patients with clots also had low numbers of platelets, which are tiny blood cells that help with clotting. Normally, someone with a low platelet count cannot form clots and bleeds as a result. But in these people, who had all recently gotten an AstraZeneca shot, an immune reaction may have set off uncontrolled clotting that bound up all their platelets.

Some scientists now hypothesize that the immune reaction is triggered by some part of the adenovirus-vector technology. If that’s true, these blood clots might show up as a rare side effect with other adenovirus-vector vaccines. But they clearly are very infrequent. The AstraZeneca and J&J coronavirus vaccines are the first adenovirus-vector shots to even be deployed widely enough in the U.S. and Europe for such rare events to emerge, but vaccines including Russia’s Sputnik V,  China’s CanSino, and J&J’s Ebola vaccine also use the technology.

mRNA vaccines are similarly new, but they have so far racked up a good safety record. So many doses have been administered that these unusual blood clots—or any serious one-in-a-million event—would very likely have shown up by now. Back in December, experts quickly noticed and warned the public about a handful of severe allergic reactions to the Pfizer-BioNTech and Moderna vaccines, which is why vaccination sites now monitor recipients for 15 to 30 minutes after the jab.

In addition, doctors have picked up on a possible one-in-a-million risk of a bleeding disorder called immune thrombocytopenia, which happens when the immune system attacks platelets after vaccination. (It’s a rare but documented side effect of some other vaccines, such as the one against measles.) These patients do have low platelet counts, but they do not have the accompanying blood clots that seem unique to adenovirus-vector vaccines.

Immune thrombocytopenia is easily diagnosed and treated, James Bussel, a pediatrics professor at Weill Cornell Medicine who studies the condition, told me in an email. But the unusual combination of blood clots and low platelets is trickier. For example, one standard treatment for clots is a blood thinner called heparin, but the drug can, in very rare cases, cause the exact combination of low platelets and blood clots that doctors are concerned about. Experts now fear that heparin might make the potential vaccine reaction even worse. This combined condition also seems to be more dangerous than immune thrombocytopenia, but the prognosis may improve as more doctors learn how to treat it.

U.S. officials expect the J&J pause to last no more than a few days, as experts review the safety data and potentially revise recommendations. After a similar pause and review of the AstraZeneca data in Europe, several countries restricted that vaccine to older residents. (Most of the 86 blood-clot cases observed with the AstraZeneca vaccine in Europe were in women under 60, as were all six cases observed with the J&J vaccine in the U.S.) The U.K. now recommends that people younger than 30 be offered a different vaccine if possible.

The recommendations take into account individual risk: For older people at high risk of severe COVID-19 complications, the benefits of the vaccine clearly outweigh the risks of a blood clot. But for young people at lower risk from the coronavirus, the benefits are not so clear. For regulators, that balance also depends on whether a country has any other vaccines available and the severity of its local COVID-19 outbreak. The European Union and the U.K. do not have as many mRNA vaccines as the U.S., and less wealthy nations have even less supply. Ultimately, every country will have to do its own benefit-risk calculation.

The U.S.’s recommendations may end up diverging from other countries’, but they may also influence them. Sean O’Leary, a pediatrician at the University of Colorado and a liaison to the CDC’s Advisory Committee on Immunization Practices, notes two historical examples. Although the United States has discontinued use of the oral polio vaccine—which is more effective and easier to administer than the shot, but also carries a one in 2.5 million risk of paralysis after infection with the live virus in the oral vaccine—the World Health Organization continues to recommend it in countries where polio is endemic.

But when the U.S. in 1999 stopped using a vaccine against rotavirus because of rare reports of intestinal blockage, the rest of the world fell in line, despite the fact that the virus was killing about half a million kids worldwide each year. “The decision was made, essentially, if it’s not good enough for you, it’s not good enough for us,” O’Leary says. Eventually, two newer rotavirus vaccines with a lower risk of complications were developed. They are now used in the U.S. and around the world.

With rotavirus, the vaccine conundrum became moot as new alternatives became available. With COVID-19, those alternatives already exist in the form of mRNA vaccines. There was no guarantee that the mRNA shots would be ready so quickly, or turn out to be so good and so safe. That they did is a great stroke of luck. But in the near future, the Pfizer and Moderna vaccines’ limited supply, high price, and distribution challenges will make them functionally unavailable to much of the world. The U.S. can afford, literally, to vaccinate most of its population with Pfizer’s and Moderna’s vaccines. Most other countries cannot.

 

By: Sarah Zhang

Source: Johnson & Johnson Blood Clots Make mRNA Vaccines Look Great – The Atlantic

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COVID-19 Vaccination Passports Worry Public Health Experts

More and more people are getting vaccinated, and some are even traveling. Which has led to a debate over whether countries should require COVID-19 vaccination passports or IDs. The European Union is proposing a so-called Digital Green Pass so vaccinated people can move more freely.

Family vacation in Italy? Business trip to China? No problem. Just show me your COVID-19 vaccine certificate. This might be the future. “I think it would certainly speed up the recovery of those sectors that have been slowed down or shut down because of risk of exposure to COVID,” said Glenn Melnick, a health economist at the University of Southern California.

Many worry about creating an underclass of unvaccinated people who also can’t travel. Dr. Wafaa el-Sadr at the Columbia Mailman School of Public Health said the U.S. still has a lot of work to do.

“I’m hopeful that if there’s a true commitment in this country to equity that we would be able to reach a point where we have been able to overcome the very real barriers that people are facing now in accessing vaccination,” she said.

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NBC News medical contributor Dr. Vin Gupta and CNBC’s senior health and science reporter Meg Tirrell join TODAY to discuss the latest news surrounding coronavirus vaccine candidates. They discuss the possibility of a vaccine passport required by businesses and events to ensure the safety of customers and employees. » Subscribe to TODAY: http://on.today.com/SubscribeToTODAY » Watch the latest from TODAY: http://bit.ly/LatestTODAY
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And if it’s going to happen, Jennifer Nuzzo at Johns Hopkins University said, universal verification systems will be needed. “You are requiring countries to show proof of having provided something that is very hard to get, that can create incentives for perhaps not being completely transparent about what’s actually going on,” she said.

As other countries start to experiment with vaccine credentials, Americans who want to travel may have to participate.

Source: COVID-19 “vaccine passports” worry public health experts – Marketplace

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Vaccine To Have Marginal Impact On Winter Pressures As Rollout Work Continues

The UK’s chief medical officers have warned the coronavirus vaccine will only have a “marginal impact” on hospital numbers over the winter as each of the four nations prepares to start administering the first doses next week.

Festive gatherings are likely to put additional pressure on healthcare services, with a tough few months still ahead, experts said.

It comes as preparations are continuing to roll out the Pfizer/BioNTech vaccine from as early as Tuesday in what has been described as “one of the greatest challenges the NHS has ever faced”.

GP surgeries in England have also been told to be ready to start staffing Covid-19 vaccination centres by December 14.

In a letter to colleagues, the four chief medical officers said this winter would be “especially hard” for the health service due to coronavirus.

“Although the very welcome news about vaccines means that we can look forward to 2021 with greater optimism, vaccine deployment will have only a marginal impact in reducing numbers coming into the health service with Covid over the next three months,” they said.

“The actions and self-discipline of the whole population during lockdowns and other restrictions have helped reduce the peak and in most parts of the four nations hospital numbers are likely to fall over the next few weeks, but not everywhere.

“The social mixing which occurs around Christmas may well put additional pressure on hospitals and general practice in the New Year and we need to be ready for that.”

The letter, signed by chief medical officer of England, Professor Chris Whitty; of Scotland, Dr Gregor Smith; of Wales, Dr Frank Atherton; and of Northern Ireland, Dr Michael McBride, said they did not expect the virus to “disappear” even once full vaccination had occurred.

The first jabs will be administered in each of the UK nations on Tuesday. In Northern Ireland it will be administered at a mass vaccination centre at the Royal Victoria Hospital in Belfast, while in Wales frontline NHS and social care staff will receive the country’s first coronavirus vaccine.

The first vaccinations will also take place in Scotland next week, while jabs will be administered at hospital hubs in England.

Meanwhile, in a letter sent out across England’s primary care networks, NHS England and NHS Improvement said GP-led vaccination centres would start administering doses from December 14.

The letter said centres would be set up with the necessary IT equipment and a fridge, while staff would be given training to ensure they are ready to administer 975 doses of the vaccine to priority patients within three-and-a-half days of delivery.

The first to receive the vaccine in these centres will be those aged 80 and over, as long as other risk factors, “clinical or otherwise”, have been taken into account.

There remain issues around how to ensure elderly residents in care homes, who have been recommended as the top priority, get access to a jab due to difficulties in storing and transporting the Pfizer/BioNTech version as its cold temperature – minus 70C – limits how often it can be moved.

HEALTH Coronavirus Oxford
(PA Graphics) Credit: PA Graphics

NHS England has not yet committed to a date to roll the vaccine out in English care homes, but Dr June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency, told the BBC on Friday that she estimated the vaccine would begin to be delivered to care homes “within the next two weeks”.

In total, some 40 million doses of Pfizer’s inoculation are on order – enough to administer it to 20 million people, with two jabs required 21 days apart.


By: https://www.itv.com

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Healthy Lifestyle

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Researchers Warn of Heightened Risk of HIV With Certain COVID-19 Vaccines

As the race to approval of a safe and effective vaccine for coronavirus disease 2019 (COVID-19) continues, a group of researchers is warning some of these vaccines could make patients more susceptible to contracting HIV.

Writing in The Lancet, the researchers are urging caution when it comes to the use of adenovirus type-5 (Ad5) vectored vaccines for COVID-19, recalling their research from a decade ago on an Ad5 vectored vaccine in 2 HIV vaccine trials.

“On the basis of these findings, we are concerned that use of an Ad5 vector for immunisation against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) could similarly increase the risk of HIV-1 acquisition among men who receive the vaccine,” wrote the researchers. “Both the HIV and COVID-19 pandemics disproportionately affect vulnerable populations globally. Roll-out of an effective SARS-CoV-2 vaccine globally could be given to populations at risk of HIV infection, which could potentially increase their risk of HIV-1 acquisition.”

There are several clinical trials assessing Ad5 vectored vaccine candidates underway, including by China’s CanSino Biologics and California-based ImmunityBio.

The group’s ”cautionary tale” stems from the Step and Phambili phase 2b trials that studied the efficacy of an Ad5 vectored HIV-1 vaccine in preventing HIV infection. Across both international studies, they found that the vaccine actually increased the risk of HIV among the vaccinated men.

The findings from the Phambili study, in particular, have important implications for the use of the vaccines in COVID-19, according to the researchers, as findings from this study showed that heterosexual men receiving the Ad5 vectored vaccine faced a consistently increased risk of HIV infection. Notably, this increased risk appeared to be limited to men, with women not having an observed increase of infection in the study.

In the Step trial, the risk of acquiring HIV was particularly high among men who were uncircumcised and Ad5 seropositive men who reported having unprotected anal sex with a partner who was HIV seropositive or who had unknown serostatus as baseline.

Of note, the vaccine in both studies did not have the HIV envelope. Meanwhile, in another study that used a DNA prime and an Ad5 vector, both of which had the HIV envelope, there was no observed increase in HIV infection.

The reason for the observed increase in HIV risk remains uncertain, although several follow-up studies have suggested a potential explanation, according to the researchers.

“The vaccine was highly immunogenic in the induction of HIV-specific CD4 and CD8 T cells; however, there was no difference in the frequency of T-cell responses after vaccination in men who did and did not later become infected with HIV in the Step Study,” they wrote. “These findings suggest that immune responses induced by the HIV-specific vaccine were not the mechanism of increased acquisition.

Participants with high frequencies of preimmunisation Ad5-specific T cells were associated with a decreased magnitude of HIV-specific CD4 responses and recipients of the vaccine had a decreased breadth of HIV-specific CD8 responses, suggesting that pre-existing Ad5 immunity might dampen desired vaccine-induced responses.”

Other exploratory studies have indicated that the vaccine enhances HIV replication in CD4 T cells or that Ad5-specific CD4 T cells could be more susceptible to HIV infection.

Jaime Rosenberg

Reference

Buchbinder SP, McElrath MJ, Dieffenback C, Corey L. Use of adenovirus type-5 vectored vaccines: a cautionary tale. Lancet. Published online October 19, 2020.doi:10.1016/S0140-6736(20)32156-5

Source: http://ajmc.com

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ENewsTrends

A new paper warns the link between COVID-19 vaccines and HIV risk.

Mayo Clinic

Nearly half of people in the U.S. diagnosed with HIV, the virus that causes AIDS, are over 50, according to the Centers for Disease Control and Prevention (CDC). HIV damages the body’s immune system, and interferes with the body’s ability to fight infection and disease. Does that make it more difficult to fight off COVID-19? Dr. Stacey Rizza, an infectious diseases specialist at Mayo Clinic, says, “We know that anybody who has a suppressed immune system may have an altered response to the virus that causes COVID-19. We know that older people whose immune systems are a little weaker, and people who have medical issues or organ diseases, are going to generally do worse with the infection.

If somebody has HIV and their immune system is weaker, meaning they’re not on therapy, or they’re earlier on in their therapy and their CD4 count is still low, they may be at risk of having a worse reaction to the virus. We will learn more about SARS-CoV-2 on people living with HIV over time.” Read more: https://newsnetwork.mayoclinic.org/di… More health and medical news on the Mayo Clinic News Network. https://newsnetwork.mayoclinic.org/ Journalists: Clean and nat sound versions of this pkg available for download at https://newsnetwork.mayoclinic.org/ Register (free) at https://newsnetwork.mayoclinic.org/re…

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