US flags heart inflammation risk after Novavax virus vaccine

This file photo taken on Nov 17, 2020 shows vials with COVID-19 Vaccine stickers attached and syringes with the logo of US biotech company Novavax. (JUSTIN TALLIS / AFP)

THE HAGUE – The US Food and Drug Administration has raised concerns about a possible risk of heart inflammation from Novavax Inc's COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease.

In Novavax's nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation called myocarditis detected within 20 days of taking the protein-based shot

In Novavax's nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation called myocarditis detected within 20 days of taking the protein-based shot.

"These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines," FDA staff wrote in briefing documents released on Friday.

Shares of the company fell nearly 14 percent after the FDA's analysis of data from the company's trial.

The agency said it had requested Novavax to flag myocarditis and another kind of heart inflammation called pericarditis as an "important identified risk" in its materials. The company has not yet agreed to do so.

Novavax, in response to the safety concerns flagged by the FDA, said natural background events of myocarditis can be expected in any sufficiently large database.

"Based on our interpretation of all the clinical data supporting NVX-CoV2373 … we believe there is insufficient evidence to establish a causal relationship," the company said in a statement.

One patient in the trial reported myocarditis after receiving placebo.

Novavax has said the shot, NVX-CoV2373, will play a role in driving vaccination among those who have been hesitant to get immunized and it has started an educational effort on vaccine choices.

"Despite the wide availability of authorized or approved vaccines, the SARS-CoV-2 pandemic is not well controlled in the US … there remains a desire for vaccines that have been developed using well-understood technology platforms," it said.

The FDA analyzed data from Novavax's trial before the Omicron and Delta variant became the dominant strains.

The vaccine showed an efficacy of 90.4 percent in Novavax's study, which enrolled adults across the United States and Mexico.

In this file photo taken on July 24, 2021 a pregnant woman is inoculated with the Pfizer-BioNTech vaccine against COVID-19 at a vaccination center in Medellin, Colombia. (JOAQUIN SARMIENTO / AFP)

Norway

COVID-19 vaccination during pregnancy appears to lower newborns' risk of coronavirus infection, according to a study conducted in Norway.

Norwegian researchers tracked 9,739 babies whose mothers received a second or third dose of a COVID-19 vaccine from Pfizer / BioNTech or Moderna while pregnant, and 11,904 babies whose mothers were not vaccinated before or during pregnancy. Overall, COVID infections were rare in the babies. But the risk of a positive COVID-19 PCR test during the first four months of life was 71 percent lower during the Delta era and 33 percent lower when Omicron was dominant for babies whose mothers got vaccinated during pregnancy compared with infants born to unvaccinated mothers, the researchers reported on Wednesday in JAMA Internal Medicine.

"There could still be a protective effect from antibodies past the first four months, but there are likely individual differences," said doctor Ellen Oen Carlsen of the Norwegian Institute of Public Health. Babies get another type of antibodies from breast milk, she noted, and the findings could partly be due to antibodies acquired from breastfeeding, or because vaccinated mothers are less likely to get COVID-19 and infect their babies.

Infants of women who received a booster shot during pregnancy had an even lower risk of COVID-19 than those of women who received just the original two-shot regimen. "This could imply that women who got vaccinated before pregnancy with two doses should consider receiving a booster dose during the last parts of pregnancy," Carlsen said.

The risk of developing long COVID after infection with the coronavirus is lower for vaccinated people than for the unvaccinated, but not by much, according to a large study from the US Department of Veterans Affairs.

Researchers compared outcomes among nearly 34,000 people who had breakthrough SARS-CoV-2 infections after receipt of vaccines from Johnson & Johnson, Pfizer / BioNTech or Moderna, and more than 113,000 unvaccinated people who were infected. The study, conducted when the Delta variant was predominant and published in Nature Medicine, found vaccination reduced the likelihood of long COVID after infection by only about 15 percent. There was no difference in type or severity of long COVID symptoms between vaccinated and unvaccinated patients.

The researchers also compared hospitalized patients with breakthrough COVID to hospitalized patients with seasonal influenza. "Breakthrough SARS-CoV-2 was associated with higher risk of death… than flu," study leader Dr. Ziyad Al-Aly of the VA St. Louis Health Care System said in a tweet. "The findings indicate that reliance on vaccines as our sole line of defense is not an optimal strategy," he told Reuters.

ALSO READ: Survey: Record 2m people in UK have long COVID-19

The Netherlands

Chaotic scenes at Amsterdam's Schiphol airport in the Netherlands recently have fueled anger among staff, travelers and politicians, as the international airport seemed ill-prepared for the influx of travelers following the easing of COVID-19 restrictions.

On April 23 a wild strike broke out among KLM airline baggage employees at the airport who were angry about high workload. In the weeks that followed, passengers got angry as well because of frequent long queues and canceled flights. This was attributed to the large inflows of travelers and staff shortages of security guards and baggage handlers.

Chaos intensified at Schiphol on May 30, with travelers even queuing hundreds of meters outside in the rain. Travelers complained and blamed the airport. Schiphol airport CEO and president Dick Benschop publicly apologized for the situation.

The Schiphol airport in Amsterdam is the Netherlands' main gateway to the rest of the world, and over the years, it has grown to become one of the largest hub airports in Europe.

During the peak periods of the COVID-19 pandemic, passenger numbers at Schiphol dropped enormously and planes were stationary, staff not needed and fired. In April 2019 before the pandemic, Schiphol saw 6.1 million passengers travel to, from and via the airport, while the airport counted only 100,000 passengers in April 2020 due to anti-pandemic measures.

With nearly all COVID-19 restrictions lifted in the Netherlands, the number of passengers has continued to grow recently. In April 2022, 4.4 million passengers flew to, from or via Schiphol. However, the staff that left during the COVID-19 crisis have not returned yet.

Whether in security, flight handling or check-in counters, there are too few employees everywhere to allow the large number of passengers who want to go on vacation or business trips to move through without too much delay.

The Netherlands Trade Union Confederation (FNV) had sent Schiphol a cry for help in October last year to prevent similar chaos as in the summer of 2021, but Schiphol ignored this "signal from the workplace," according to the FNV. Recently, the union warned in a letter to Schiphol about a "hot summer" if an agreement was not reached soon.

Minister of Infrastructure and Water Management Mark Harbers urged Schiphol to do everything possible to prevent new chaos, while acknowledging that more sectors had start-up problems as COVID-19 restrictions eased.

On Tuesday evening, just before the deadline of the FNV, Schiphol and the union came to an agreement, which was presented to the House of Representatives.

In the forthcoming summer, passengers at Schiphol will nevertheless have to take into account crowds and queues that are longer than usual, Benschop and Van Doesburg both explained. But the general agreement concluded on Tuesday between Schiphol and the union is expected to help improve the situation.