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.