Belatedly, three items of recent pandemic news: Novavax and the EU; a detailed study of long haulers in the VA health care system; and the imminent authorization of Pfizer’s vaccine for young adolescents. Plus news briefs and a frippery.
Authorization soon for Pfizer shots in kids 12-15
According to reporting first published by the NY Times, the FDA is on the verge of granting Pfizer’s request to amend the emergency use authorization for its vaccine — allowing shots in teenagers 12 to 15 years old. The approval could come this week or early next, and the day after it drops the CDC’s advisory committee ACIP is expected to make its recommendation spelling out how the vaccine can be used.
Pfizer’s chairman and CEO Albert Bourla told investors on Tuesday morning that an FDA decision is expected “shortly.” He also said the company will apply in September to extend the EUA to children 6-11 and 2-5 years old. An application for still younger children, ages 6 months to 2 years, could come in the fourth quarter, pending results of ongoing studies.
A close look at long Covid
A large study from patient records in the Department of Veterans Affairs health system shows that even people who have a mild or asymptomatic case of Covid-19 bear significant risks in the following months, including a 60% greater risk of dying. The study looked in minute detail at scores of different symptoms of long Covid and their occurrence in 73,000 post-Covid patients from 1 to 6 months after their infection. Here is the paper in Nature. (Download the PDF to peruse the rather elaborate charts of dozens of symptoms tracked across multiple patient categories, as at upper left.)
The study also looked at over 13,000 Covid-19 patients with more serious disease, and unsurprisingly found that the occurrence of long-term symptoms increased with the increasing severity of the patients’ acute phase — from hospitalization to ICU to intubation.
Still, the main takeaway from the study is how hard this disease hits even those with a milder presentation. While the VA cohort is not representative of the US as a whole (these people are older, more male, and more Black), the incidence of long Covid symptoms is sobering when projected to 32 million Americans who have contracted Covid-19.
Novavax deal with EU is close
The company, whose vaccine has not yet been approved in the US or the EU (or anywhere else), nonetheless has put together the most extensive manufacturing network of any vaccine maker. Having taken $1.6 billion from Operation Warp Speed in exchange for the promise of 100 million doses for the US, Novavax is now also planning to supply 200 million to the EU (mostly to be delivered in 2022) and 1,100 million to the COVAX initiative.
Politico is reporting on the consensus that Novavax will get the nod from US regulators before AstraZeneca does. Regulatory approval from the EU will probably happen first.
In other Novavax news, the company is expanding its Phase III trial in the US to include 3,000 adolescents aged 12-17 years.
- EU opening plan — We mentioned last week that Europe was working towards opening up to US tourists and other non-essential travelers. The plan is out now in draft form (Washington post article; EU press release; EU document). What is different from earlier reports: the plan would allow vaccinated travelers from many countries and regions, not just the US; and unvaccinated travelers would be welcomed after testing and possible quarantine, if they come from countries in which the virus is sufficiently under control. This could all happen by the end of June.
- MN reports six cases of a variant from India — B.1.617 is officially designated by WHO as a variant of concern. It has not been proven to be more transmissible (as the UK’s B.1.117 has) or more deadly (like Brazil’s P.1); but it may be either or both. MinnPost reports: “The six people were from three households, and people from two of those households had a known association with travel.”
- For the recovered, one shot is good against variants — The good news is, if you have had Covid-19 and get one shot of a vaccine, you are probably proof against reinfection, including with variant viruses. The bad news: those naïve to the virus could be vulnerable to variants after a single shot. This could bode ill for the UK, where the policy is to delay people’s second shot for 12 weeks in order to make the vaccine supply stretch further. Here are a summary in CIDRAP and the paper from Science Magazine.
- One million rapid at-home tests — The latest Covid relief package featured $50 billion to study and expand testing. Part of it is being spent on a study in Greenville, NC of how home rapid-testing kits might fit into a strategy to reduce transmission of SARS-CoV-2. (If only we had begun this work a year ago, as Michael Mina and others have been urging.) A million Quidel test kits are being distributed to 40,000 families in Greenville, and participants are asked to have the most-exposed family member self-test three times a week. The Washington Post reporting linked above mentions that in the UK, every resident is being supplied with at-home rapid testing for twice weekly use.
- Moderna commits half a billion doses to COVAX — The company has pledged to sell the vaccine at the lowest possible price to COVAX, the WHO/CEPI/Gavi program to distribute shots to the poorest countries in the world. Deliveries would start in Q4 this year and continue in 2022. The price has not been made public.
To reward your patience, the frippery today is a mind-blowing optical illusion. All the balls in that image are identical — they are all the same color. The image was created by David Novick, and he has a million more in the same vein.