Friday Update for 2021-04-02: Emergent
Three items of pandemic news you may have missed recently: Moderna can pack more doses per vial; Emergent’s big mistake; and news on vaccines for kids as young as 12. Plus news briefs and a pair of fripperies.
Pfizer is good down to age 12
Pfizer and BioNTech have been testing their vaccine in children aged 12 to 15, and now they have announced preliminary results (press release): the shot was 100% effective in that population and was well tolerated.
The companies say they will submit an amendment to the FDA asking that its Emergency Use Authorization be modified to allow the use of Comirnaty in children as young as 12. They also plan to ask regulators worldwide to make the same modification. The hope is that kids might begin getting shots before school opens in the fall.
The vaccine generated antibodies in 2,260 young teens at levels well above those seen when people aged 16 to 25 were vaccinated: a geometric mean titer of neutralizing antibodies of 1,239.5, vs. 705 in the older cohort. In the placebo arm of the study, 18 kids developed Covid-19; none did among those receiving the vaccine.
Here is more coverage of the Pfizer / BioNTech results.
In a separate development, Johnson & Johnson announced that they are extending their ongoing Phase II-a trial to children ages 12 to 17. The vaccine is currently authorized for ages 18 and up.
Emergent’s big mistake will delay J&J delivery
The Emergent factory in Baltimore is signed up to help both AstraZeneca and Johnson & Johnson with the manufacture of their vaccines. (See the figure depicting virus makers’ manufacturing agreements — it is updated frequently.)
One or more employees at Emergent, apparently, made a big mistake: mixing up materials for the products of the two vaccine makers. The problem was caught in quality control; the end result was the spoiling of 15 million potential doses of J&J’s shot.
J&J has confirmed the error. The company made its number for its March commitment to the US government: 20 million doses. The shortfall is going to hit in April. The upshot is that J&J, which had been saying it would deliver 100 million more doses by the first of May, is now backpedaling a bit and saying “by the first of June, and we hope for May.”
This Emergent plant, which took nearly a billion dollars of Project Warp Speed money in 2020, is no stranger to quality problems. As it happens, the FDA dinged Emergent in April 2020 after an inspection found significant errors in training and procedure. Weeks later the Warp Speed investment was announced.
Moderna can pack more doses per vial
The FDA authorized the company to ship vaccine in vials of two sizes, a smaller one that can contain up to 11 doses (previously it was 10), and a larger with up to 15 doses. Here are Moderna’s press release and the FDA announcement.
In addition the FDA relaxed the rules around how long vaccinators have to put the vaccine into arms after removing it from a freezer. The maximum time at room temperature is now 24 hours; it was 12. And staff at a vaccination site now have 12 hours after first puncturing a vial to use the vaccine, up from 6 hours previously. These changes are based on new documentation that Moderna supplied to the FDA testifying to the vaccine’s stability with time and temperature.
- Moderna’s variant and booster trial — The company has tweaked its authorized vaccine to target B.1.351, the variant of concern out of South Africa, and the first trial shots have gone into arms. By the end of April the trial will sign up 210 people and look at 10 different dosing regimes: two or three shots, in people who were vaccinated or are vaccine-naïve, in varying doses, of the original formulation or the B.1.351 version.
- Pfizer ready to apply for full full approval — After the company has observed 12,000 fully vaccinated people for six months, its CEO said, “These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the US FDA.”
- Vaxzevria (AZ) — Following in the footsteps of Pfizer’s Comirnaty, AstraZeneca has chosen the trade name Vaxzevria for its (now somewhat beleaguered) shot, formerly called AZD1222 and ChAdOx1 nCoV-19. The new name has just been approved in Europe; there is no word on whether the company has made a similar application in the US.
- Heterologous prime-boost — This is the term for mixing and matching shots of two separate vaccines, which we have been talking about for a while now. The NY Times has an update on this question and the animal and clinical trials under way to investigate it. One of these, the Com-COV study, is working the combinations of the two vaccines now authorized in the UK; more shots may be added with time. Other research groups are interested in the mix-and-match, and with 13 vaccines currently authorized around the world, they will have plenty of material to work with.
Two fripperies today. The first is a collection of paired photographs from a Czech artist, Jan Langer. Each shows a young adult and the same person at age 100. Langer notes on his site that Czechia now has about 1,200 centenarians (in a population of 10.6 million), and in 50 years will have 14,000. The photographer posed his elderly subjects to mimic their attitude in the older portraits, and matched the new captures to the cast and coloration of the older ones.
Your second frippery involves 250,000 dominoes. After the kickoff domino is disturbed, a carefully prepared field the size of a basketball court proceeds to topple in multiple chain reactions. It all takes 14 minutes and you will not even be tempted to look away. This massive Rube Goldberg machine with dominoes was designed and built by a team of 19 people from all around the world. Did you know there is an occupation called “professional domino / chain reaction artist?” I didn’t.
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