Spring, the most inspiring of the seasons (this year especially)

(CNN)As the end of the pandemic tunnel gets brighter and brighter, has a season ever better aligned with where most people are in the world right now?Spring is the season of hope — that things will get better after they were worse. The river will “flow again after it was frozen,” Ernest Hemingway wrote of spring in “A Moveable Feast.” Change is a-comin’, and everything is going to be better for it.”If we had no winter, the spring would not be so pleasant,” wrote English poet Anne Bradstreet. “If we did not sometimes taste of adversity, prosperity would not be so welcome.”Spring is arguably the most profound of the seasons in terms of its meaning, promise, inspiration and experiences. It is the season of new starts and ideas bursting from the ground like the return of grass, daffodils and cherry blossoms.

Snake venom is a boon in search for life-saving drugs

(CNN)Over the summer, Chicago-based cardiologist Dr. Sandeep Nathan received a phone call that a patient was in trouble.Every minute that went by put the patient more atrisk. In his mid-30s, he was suffering from a massive heart attack with excessive blood clotting in the vessels around his heart. He had also tested positive for Covid-19.Several studies have shown that coronavirus impacts more than just the lungs and respiratory system — including the heart. “There is an acute inflammatory response, increased blood clotting and cardiac involvement,” cardiologist Dr. Nieca Goldberg, medical director of New York University’s Women’s Heart Program, previously told CNN Health. Goldberg is also a senior adviser for women’s health strategy at NYU Langone Health.

Before beginning a procedure to clear the vessels and put in stents, Nathan and his team administered blood thinners, including Integrilin, to help break up the clots.

The US Food and Drug Administration first approved Integrilin in 1998, and medical professionals commonly prescribe it to heart attack patients. But what manypeople don’t realize is the drug was originally derived from a protein found in the venom of the pygmy rattlesnake.

“Several hundred thousand heart attacks occur in the United States every year, and a significant proportion of these heart attacks are treated with agents, which unbeknownst to both the physician and patient, are actually derived from animal venom,” said Nathan, director ofthe University of Chicago Medicine’s Coronary Care Unit and co-director of its Cardiac Catheterization Lab.”There’s a bit of a misconception that drug development, particularly with antiplatelets or anticoagulants, is now passé — that we’ve discovered everything that we need to know,” he added. “In my opinion, nothing could be further from the truth.”http://Snake venom is a boon in search for life-saving drugs

COVID-19 vaccines are safe and effective in pregnancy, new study shows

The Moderna and Pfizer COVID-19 vaccines trigger strong immune responses in pregnant and breastfeeding women, equivalent to that of other women of reproductive age, preliminary research shows. 

The data also suggests that the vaccines are equally safe in all women of reproductive age, and that they likely offer at least some protection to fetuses through the placenta, and to newborns through breast milk.

That said, the study, posted March 8 to the preprint database medRxiv, has not been peer-reviewed and included a relatively small group of participants; a total of 131 vaccinated women participated in the study, including 84 pregnant, 31 breastfeeding and 16 non-pregnant women. For comparison, the study authors also analyzed banked blood samples from 37 women infected with COVID-19 during pregnancy.

“This is preliminary evidence … but from the results that are presented, vaccines work well in pregnant and lactating women, and similar to non-pregnant persons, and better than natural immunity [immunity gained from catching the virus itself]”, said Dr. Denise Jamieson, the chair of the Department of Gynecology and Obstetrics at Emory University School of Medicine, who was not involved in the study. 

These results align with data presented in other preliminary studies, as well as a recent report by the Centers for Disease Control and Prevention (CDC), which is monitoring for vaccine-related side effects through its v-safe smartphone app and has a specific registry for pregnant people, Jamieson added.

Scientists suspected that COVID-19 vaccines would be safe and effective in pregnant and breastfeeding people, but they lacked hard data because these demographics were excluded from vaccine trials, Live Science previously reported. The new study is an important “first step” to confirming the positive results that scientists anticipated, said Dr. Stephanie Gaw, an assistant professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, who was not involved in the study.

Good news so far

The new research only considered the Moderna and Pfizer vaccines because those were the only COVID-19 shots authorized for emergency use at the time of the study. Both vaccines contain mRNA, a type of genetic material that encodes instructions for cells to build proteins. 

Once inside the body, the mRNA instructs cells to build spike proteins, a structure that sticks out of the coronavirus. The immune system learns to recognize the spike and destroy the attached virus. The mRNA then quickly degrades, remaining in the body for a few days, at most, according to Horizon, the European Commission’s research magazine.

Not all the COVID-19 vaccines use mRNA; for instance, the Johnson & Johnson shot contains a modified common cold virus. Future studies will need to assess non-mRNA vaccines in pregnant people, but for now, the new study offers tentative “good news” for the Moderna and Pfizer shots, Jamieson said.

The study participants provided blood samples at the time of their first and second vaccine doses, and then again two to six weeks after their second dose. Those who gave birth during the study also provided a sample at the time of delivery. The researchers screened these blood samples for SARS-CoV-2 antibodies, molecules that bind to the coronavirus and mark it for destruction. 

“Strikingly higher levels of SARS-CoV-2 antibodies were observed in all vaccinated women compared to pregnant women with natural infection,” the study authors wrote.

Of the pregnant participants, 13 gave birth during the study period, and the study authors were able to analyze umbilical cord blood from 10 of them. All 10 umbilical cord samples contained vaccine-generated antibodies, suggesting that immune protection against SARS-CoV-2 had passed from the mothers to their infants. 

All the breast milk samples collected after vaccination also tested positive for antibodies. After the second shot, a type of antibody called immunoglobulin G, or IgG, significantly increased within the milk. At this point, it’s unknown how much protection these antibodies offer newborns or how long that protection will last, but this study sets a starting point for investigation, Gaw said. 

All women in the study experienced similar types of side effects, such as headache, soreness and rashes at the injection site. They also experienced these side effects at similar rates, regardless of whether they were pregnant, breastfeeding or neither. 

A subset of women in each group experienced fever and chills, most commonly after their second vaccine dose. This included about one-third of the pregnant group, highlighting that those who receive the vaccines in pregnancy should monitor for this side effect, the study authors noted.

Fevers — particularly long-lived, high-grade fevers — have been associated with a heightened risk of miscarriage and certain birth defects, Gaw said. High-grade fevers in the first trimester pose the most significant risk, but “a low-grade fever is probably of little consequence, especially a short-lived one,” she said.

If vaccinated pregnant women do develop a fever, “it’s important to get the temperature down with acetaminophen,” Jamieson said. She said she recommends that patients only take the drug once they feel a fever coming on, rather than taking acetaminophen before getting vaccinated. And “it’s important to remember that COVID can cause prolonged fever,” so not getting vaccinated carries its own risk, she said.

Remaining questions 

While the new study suggests that the vaccines work well in pregnant women and breastfeeding moms, the researchers did not explore potential risks to the fetus, the study authors wrote. 

Theoretically, it would be concerning if mRNA from the vaccine reached the placenta and caused inflammation of the tissue, Gaw said. Alternatively, the mRNA could also spark an immune reaction in the fetus if it crossed the placenta, she said. Because the mRNA degrades so quickly, though, it’s unlikely that any meaningful amount reaches the placenta, Live Science previously reported. In any case, Gaw and her colleagues plan to study inflammation in vaccinated mothers and babies after birth to address this potential risk.

There’s also a question of whether mRNA could pass through the breast milk. Gaw and her colleagues conducted a small study of six vaccinated individuals and found no mRNA in their breast milk; the study, posted March 8 to medRxiv, has not been peer-reviewed, but hints that this shouldn’t be a problem. 

Looking ahead, scientists also need to determine whether pregnancy outcomes are similar between vaccinated and unvaccinated women,  Jamieson said.

“The CDC is rapidly gathering that information through v-safe,” she noted. As of mid-March, more than 30,000 pregnant women had received either the Moderna or Pfizer vaccine and had registered with v-safe, according to Medscape Medical News. Of those, 275 have since completed their pregnancies, and within that group, the rate of complications, such as miscarraige, still birth and preeclampsia, was no higher than what’s seen in the general population.

“It was all very reassuring, but we need more information,” Jamieson said.

In general, research suggests that pregnancy may increase the risk of severe COVID-19, ICU admission, need for ventilation and death from the virus, according to the American College of Obstetricians and Gynecologists (ACOG). Given what we know so far, pregnant women at high risk of exposure to the virus should seriously consider the vaccine, Gaw said. 

This would include health care workers, in particular, as well as other essential workers and teachers, she said. But if a pregnant person is able to minimize their risk of COVID-19 exposure through physical distancing, they could opt to wait to get the vaccine after more data comes out, she said. Future studies could also hint at which stage of pregnancy would be best for vaccination, especially in terms of maximizing protection for the newborn, she added.  

AstraZeneca COVID-19 vaccine ‘safe and effective’ amid blood clotting reports, EU regulator says

A safety committee with Europe’s regulator concluded AstraZeneca’s COVID-19 vaccine is safe and effective, with no ties to an overall increased risk of blood clots in vaccinated individuals. However, a definitive link to serious blood disorders could not be ruled out.

Top officials with the European Medicines Agency said the benefits of the vaccine against COVID-19 and its associated hospitalizations and deaths continue to exceed the risks of side effects.

“PRAC [the safety committee] noted the number of thromboembolic events reported after vaccination [469 reports] is lower than the expected in the general population and PRAC has concluded that there is no increase in the overall risk of blood clots with this vaccine,” said Dr. Sabine Straus, chair of the safety committee.

Straus noted the vaccine is effective against COVID-19 disease, and likely reduces the risks of blood clotting events overall. However, insufficient evidence prevented the committee from concluding that serious adverse events were not vaccine-related.

As of Wednesday evening, the committee noted “very rare” case reports of serious blood disorders, including seven causes of clotting in multiple blood vessels within seven to 14 days post-vaccination, and 18 reports of clots in vessels draining blood from the brain. The serious case reports come amid a backdrop of nearly 20 million vaccinations across Europe.

The EMA said the safety committee will continue to run investigations to assess reports. The agency stressed awareness of the risks for both patients and providers, and advised including the risks in the vaccine’s product information.

Emer Cooke, executive director of the EMA, stopped short of weighing in on some member states’ paused AstraZeneca vaccine campaigns. Rather, the regulator’s “responsibility,” Cooke noted, “is to come to a conclusion as to whether or not the benefits outweigh the risks of the vaccines so that countries can make an informed decision and increase trust in the vaccine.”

Germany, France, Italy and Spain joined the growing list of mostly European countries — starting with Denmark last week — that temporarily halted the use of the AstraZeneca vaccine in recent days to investigate cases of blood clots that occurred after vaccination. Others include Thailand and Congo.

Biden: All U.S. adults to be eligible for vaccines by May, some normalcy coming by summer

WASHINGTON (Reuters) – President Joe Biden told U.S. states on Thursday to make all adults eligible for a coronavirus vaccine by May 1 and urged Americans to stay vigilant or face more restrictions, hours after he signed a $1.9 trillion stimulus bill into law.

In a forceful but somber speech from the White House on the first anniversary of the pandemic lockdown, Biden said if Americans pulled together there could be a greater sense of normalcy – and some backyard barbecue parties with small groups – on the U.S. Independence Day holiday on July 4.

That date is a new goal for the president and a projection of hope amid a pandemic that has killed more than 530,000 people in the United States, the most of any country.

To achieve his summer target, Biden said he needed Americans’ help.

“If we don’t stay vigilant and the conditions change, then we may have to reinstate restrictions to get back on track,” he said in an evening address from the White House, his first in television prime time since becoming president.

“We’ve made so much progress. This is not the time to let up. Just as we are emerging from a dark winter into a hopeful spring and summer is not the time to not stick with the rules,” he said.

South African coronavirus variant detected in New York resident

New York has confirmed a case of the South African coronavirus variant in a Nassau County resident.

The case was discovered through sequencing at a city-based commercial lab, and no other details were given in an announcement posted Sunday, such as the patient’s condition, travel history or when the case was confirmed.

Gov. Andrew Cuomo noted a drop in statewide positivity and hospitalizations, allowing a further push on reopenings, but amid news of the variant, urged residents to double down on mitigation measures like face masks, hand hygiene and social distancing.

“…With the discovery of a case of the South African variant in the state, it’s more important than ever for New Yorkers to stay vigilant, wear masks, wash hands and stay socially distanced.” Cuomo said, in part, in a statement posted Sunday. “We are in a race right now — between our ability to vaccinate and these variants which are actively trying to proliferate — and we will only win that race if we stay smart and disciplined.”

The news follows a separate announcement from last Monday, when the state confirmed the variant in a patient who was transferred to a city hospital from Connecticut. At the time, Cuomo said that there was no evidence of further spread pertaining to the case.

Several mutated versions of the virus have caused significant concern among experts because they have shown to diminish vaccine efficacy, including variants first identified in South Africa, B.1.351, and the United Kingdom, B.1.1.7. These strains involve changes along the surface spike proteins that allow the pathogen to bind more tightly to healthy cells. 

Data from the Centers for Disease Control and Prevention notes the B.1.351 variant has been reported in 22 cases across ten states, with 44 states reporting over 1,660 cases of the B.1.1.7 strain, which has been projected to become the dominant strain in the U.S. by March.

Several companies are exploring variant booster shots in a bid for more protection against the strains. Both Pfizer and Moderna have said protection against the B.1.351 variant in particular remains unclear. Studies have suggested the variant dropped the Pfizer vaccine’s neutralization power by about two-thirds, while Moderna saw a six-fold reduction in neutralizing antibodies.