Covid-19 roundup: Trump administration planning to speed up shots; EMA to review AstraZeneca/Oxford vaccine
Following reports from Joe Biden’s transition team that the President-elect is planning to release nearly every available dose of Covid-19 vaccines when he takes office, the Trump administration is planning to speed up vaccinations before next week’s inauguration.
New federal guidelines planned for Tuesday will recommend letting everyone older than 65 get a vaccine, as well as all adults at high risk for infection, according to reports from Axios and the Associated Press. The move would get shots into arms rather than holding some doses back for second shots of two-dose regimens.
States would then determine who should get the vaccine based on CDC guidelines. The vaccination push would also expand where people can get vaccinated to include community health centers and more pharmacies. In California’s case, baseball stadiums and Disneyland will also serve as vaccination centers, per a New York Times report.
Trump’s HHS had been holding back the second shots despite claims from critics that Covid-19 vaccines were not being distributed quickly enough. Government officials have distributed more than 25 million doses across the country, but only 9 million Americans have received shots, the CDC said Monday.
Biden has made it a priority of his incoming administration to try to vaccinate as many people as possible, pledging to get 100 million shots into arms in his first 100 days. It’s yet to be seen whether he can ramp up distribution quickly enough to meet that goal.
EMA could authorize AstraZeneca/Oxford vaccine by the end of January
AstraZeneca and Oxford University, whose Covid-19 vaccine trials ran into trouble over the summer due to adverse events, could see its jabs authorized in Europe by the end of the month.
The review of the vaccine is slated to proceed under an accelerated timeline, the EMA said Tuesday, with a possible authorization decision coming Jan. 29. Though that date is only less than three weeks from now, the agency said it has already looked at some data from the pharma as part of its rolling review process.
If endorsed by the EMA’s CHMP and formally authorized by the European Commission, the AstraZeneca/Oxford vaccine would become the third available on the continent, after the Pfizer/BioNTech and Moderna vaccines.
Though the AstraZeneca/Oxford vaccine is cheaper and easier to distribute, concerns arose over its data readouts that showed it was only 70% effective on average, compared to figures in the mid-90% range by rivals. Some researchers pointed out that a subpopulation who had accidentally received a half-dose and then a full-dose saw an effectiveness greater than 90%, although that ended up raising more questions.
But the company received a vote of confidence in late December when the vaccine was authorized by the UK. CEO Pascal Soriot has teased a new approach here, as experts say the vaccine could be more effective when given three months apart as opposed to the 28-day schedule conducted during its trials.
Vir and GSK antibody to be examined in NHS-backed study
The NHS is backing a small trial for a new Covid-19 treatment in an outpatient setting.
Vir and GSK are teaming up for a Phase Ib/IIa study to evaluate VIR-7832 in patients with mild to moderate Covid-19 cases, the companies said Tuesday morning. The program is a neutralizing antibody with preclinical data suggesting an ability to clear infected cells and the potential to enhance virus-specific T-cell function, protecting healthy cells from the virus.
The pair hope the latter aspect could help treat, and possibly prevent, Covid-19 infection.
This study will be the first to test the candidate in humans. In the Phase Ib portion, 24 participants will be randomized 3:1 to receive one dose of the experimental drug or placebo, after which the chosen dose will move into Phase IIa.
Then, Phase IIa will include three treatment arms: 50 patients randomized to VIR-7832, 50 patients to a separate program, VIR-7831, and 25 patients to placebo. The co-primary endpoints are safety and virologic activity of VIR-7832, as measured by a change in SARS-CoV-2 viral load from baseline to day eight.
Tuesday’s announcement stems from an April collaboration agreement between Vir and GSK. VIR-7831, the second program included in the Phase IIa portion, was selected by the NIH in December for a study in moderately ill hospitalized patients.
IRC warns of inequitable Covid-19 vaccine distribution
The International Rescue Committee, a humanitarian aid organization founded by Albert Einstein in the 1930s, is warning that billions of people around the world may not receive Covid-19 vaccinations this year.
Global shortages of vaccines, coupled with “vaccine nationalism,” will result in the majority of people in low-income and conflict-affected areas missing out on vaccines in 2021 or possibly for many years, the organization said. The WHO-backed initiative COVAX, which aims to get vaccines to these areas, estimates that at most 20% of these populations will get vaccinated by the start of next year.
IRC also noted concerns about the requirement for many of the authorized vaccines to be stored in extremely cold temperatures.
Mesfin Teklu Tessema, senior health director for the International Rescue Committee, said in a statement:
“To ensure no one is left behind, investments must be made immediately to strengthen health systems. This includes shoring up supply chains, allocating sustainable and adequate financing, and empowering frontline and community health workers, who can deliver care directly to those in need within their local settings. To do this, we urge high-income countries to increase their investments to both the COVAX facility and broader humanitarian assistance that remains every bit as essential, especially given the severity of COVID-19’s secondary impacts.
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