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COVID-19 Roundup: Moderna Neutralizes Delta Variant; FDA on Heart Inflammation Risk; and Vaccination During Pregnancy Studied

Moderna: Studies Find Vaccine Effective Against Delta, Other COVID-19 Variants

The COVID-19 vaccine from U.S. biotech firm Moderna is effective against the highly contagious Delta variant, Moderna stated in a news release this week, recounting results of recently completed studies that found the vaccine to have a neutralizing effect against most variants.

U.S. public health officials are concerned mostly about the Delta variant, first identified in India, which could become a new public health threat, primarily because it is more contagious and could be deadlier for the unvaccinated, according to the U.S. Centers for Disease Control and Prevention (CDC). It is estimated that the Delta variant currently represents up to 20 percent of cases in the U.S.

Moderna said blood samples from fully vaccinated individuals produced antibodies against multiple variants and researchers measured only a “modest reduction in neutralizing titers” against the Delta variant. A titer is a laboratory test that measures the amount of antibodies in blood.

“These new data are encouraging and reinforce our belief that the Moderna COVID-19 Vaccine should remain protective against newly detected variants,” Stéphane Bancel, Moderna’s chief executive officer, said in a statement. “These findings highlight the importance of continuing to vaccinate populations with an effective primary series vaccine.”

While highly effective against the Delta variant, the Moderna study showed the vaccine was less effective against variants, compared to the original strain of the virus.

Nonetheless, the findings reflect other studies that found both so-called mRNA vaccines — from Moderna and Pfizer-BioNTech — are highly effective against the delta variant. A study published this month in Nature found that Pfizer’s vaccine was able to neutralize variants including Delta, though at somewhat reduced strength.

Moderna stated it is pursuing a “clinical development strategy against emerging variants to proactively address the pandemic as the virus continues to evolve.”


FDA Adds Potential Risk of Rare Heart Inflammation to Guidelines on COVID Vaccines

The U.S. Food and Drug Administration has revised its guidelines for the Moderna and Pfizer-BioNTech COVID-19 vaccines, adding that there may be increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccinations.

This update follows “an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices,” the FDA said. However, health officials stress that the benefits of receiving the vaccine still outweigh any risk, including that of myocarditis or pericarditis.

“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” Janet Woodcock, acting FDA commissioner, said in a statement. “The benefits of Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and related, potentially severe, complications,” she said.

The CDC has identified more than 1,200 cases of a myocarditis or pericarditis mostly in people 30 and under who received the shots of either the Moderna or Pfizer vaccines. The vast majority of these individuals have recovered. Myocarditis and pericarditis typically can be successfully treated and monitored. More than 300 million shots had been administered across the U.S., according to the CDC. There have been just 12.6 heart inflammation cases per million doses for both vaccines combined.


U.S. Study to Focus on COVID-19 Vaccination During Pregnancy and Postpartum

A new study has begun that is evaluating the immune responses produced by COVID-19 vaccines given to pregnant or postpartum women, according to the National Institutes of Health (NIH).

Researchers will evaluate antibody responses in vaccinated participants and their infants. They will measure “the development and durability of antibodies” in women vaccinated during pregnancy or the first two postpartum months, the NIH said. Researchers also will review vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants “across the placenta and through breast milk,” the NIH stated in a news release.

The study, called MOMI-VAX, is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. MOMI-VAX is conducted by the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC).

“Tens of thousands of pregnant and breastfeeding people in the United States have chosen to receive the COVID-19 vaccines available under emergency use authorization,” said NIAID Director Anthony S. Fauci, M.D., in a statement. “However, we lack robust, prospective clinical data on vaccination in these populations.”

Pregnant women with COVID-19 are more likely to be hospitalized, be admitted to the ICU (intensive care unit,” require mechanical ventilation, and die from the illness than their non-pregnant peers, the NIH said.

“The results of this study will fill gaps in our knowledge and help inform policy recommendations and personal decision-making on COVID-19 vaccination during pregnancy and in the postpartum period,” Dr. Fauci said.