More questions for J&J vaccine boosters ahead of FDA review

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Associated Press 14 October, 2021 - 11:58am

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Data presented in this work were obtained at the W. M. Keck Observatory from telescope time allocated to the National Aeronautics and Space Administration through the agency’s scientific partnership with the California Institute of Technology and the University of California. This work was supported by the University of Tasmania through the UTAS Foundation, ARC grant DP200101909, and the endowed Warren Chair in Astronomy. We acknowledge the support of ANR COLD WORLDS (ANR-18-CE31-0002) at the Institut d’Astrophysique de Paris and the Laboratoire d’Astrophysique de Bordeaux. D.P.B., A.B., N.K., C.R. and S.K.T. were supported by NASA through grant NASA-80NSSC18K0274 and by NASA award no. 80GSFC17M0002. E.B. acknowledges support from NASA grant 80NSSC19K0291. Work by N.K. is supported by JSPS KAKENHI grant no. JP18J00897. C.D. acknowledges financial support from the State Agency for Research of the Spanish MCIU through the ‘Center of Excellence Severo Ochoa’ award to the Instituto de Astrofísica de Andalucía (SEV-2017-0709), and the Group project ref. PID2019-110689RB-I00/AEI/10.13039/501100011033. D.V. gratefully acknowledges the support of the STFC via an Ernest Rutherford Fellowship (grant ST/P003850/1).

School of Natural Sciences, University of Tasmania, Hobart, Australia

J. W. Blackman, J. P. Beaulieu, A. A. Cole & A. Vandorou

Sorbonne Universités, UPMC Université Paris 6 et CNRS, UMR 7095, Institut d’Astrophysique de Paris, Paris, France

J. W. Blackman, J. P. Beaulieu, C. Danielski, C. Alard & V. Batista

Laboratory for Exoplanets and Stellar Astrophysics, NASA/Goddard Space Flight Center, Greenbelt, MD, USA

D. P. Bennett, C. Ranc, A. Bhattacharya & N. Koshimoto

Department of Astronomy, University of Maryland, College Park, MD, USA

Instituto de Astrofísica de Andalucía (IAA-CSIC), Granada, Spain

UCL Centre for Space Exochemistry Data, Didcot, UK

Department of Astronomy, University of California Berkeley, Berkeley, CA, USA

Institute for Natural and Mathematical Sciences, Massey University, Auckland, New Zealand

Las Cumbres Observatory, Goleta, CA, USA

Centre for Exoplanets and Habitability, University of Warwick, Coventry, UK

Department of Physics, University of Warwick, Coventry, UK

Centre for Space Domain Awareness, University of Warwick, Coventry, UK

Department of Astronomy, Graduate School of Science, The University of Tokyo, Tokyo, Japan

Laboratoire d’Astrophysique de Bordeaux, University of Bordeaux, Pessac, France

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J.W.B. led the photometric and formal analysis and wrote the manuscript. J.W.B., V.B. and J.P.B. took and reduced the photometric data using a pipeline written by J.W.B. and A.V. with contributions from J.B.M. for magnitude calibrations. D.P.B., J.P.B. and A.A.C. discussed the conceptual and analysis approaches. D.P.B. was the principle investigator of the Keck telescope proposal, led the planning of the observations, and conducted the light curve modelling and Bayesian analyses. C.D. provided insight into single and double white-dwarf planetary systems. I.B. processed the detrended MOA photometry. A.B. and E.B. assisted with proper motion calculations. A.B. and N.K. assisted with observing on Keck. C.R. calculated the parallax, proper motion and lens prediction contours. C.A. worked on the PSF analysis and the determining of detection limits. D.P.B., J.P.B., A.A.C., C.D., S.K.T. and D.V. contributed to the review and editing of the manuscript.

Correspondence to J. W. Blackman.

The authors declare no competing interests.

Peer review information Nature thanks Albert Zijlstra and the other, anonymous, reviewer(s) for their contribution to the peer review of this work. Peer reviewer reports are available.

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

(a) OGLE-III image of the OGLE-BLG176.8 field (b) H-band image of the same field taken in 2015 with Keck/NIRC2 with the narrow camera.

(a) Keck/NIRC2 H-band image from 2018. (b) Residuals after fitting the PSF using multiple stars in the neighbourhood of the source. Both the object to the north-east (upper left in panel A) and the object at source position (lower right) are subtracted using this PSF fit. There is no structure or indication of a double star in either of the two objects. (c) The residuals from panel B normalized to the Poisson noise. (d) Panel A but subtracting the fitted PSF from the unrelated companion.

H-band adaptive optics imaging from the KECK observatory, with contours showing the predicted position of a white dwarf lens (analogous to Fig. 1) (a) A crop of a narrow-camera H-band image obtained with the NIRC2 imager in 2015 centered on MOA 2010-BLG-477 with an 8 arcsec field of view. (b) A 0.36 arcsec zoom of the same image. The bright object in the center is the source. To the north-east (the upper left) is an unrelated H = 18.52 ± 0.05 star 123 mas from the source. (c) The field in 2018. The contours indicate the likely positions of the white dwarf host (probability of 0.393, 0.865, 0.989 from light to dark blue) using constraints from microlensing parallax and lens-source relative proper motion.

Blackman, J.W., Beaulieu, J.P., Bennett, D.P. et al. A Jovian analogue orbiting a white dwarf star. Nature 598, 272–275 (2021). https://doi.org/10.1038/s41586-021-03869-6

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Read full article at Associated Press

FDA Says J&J Covid Vaccine Booster Data Is Limited

NBC News 14 October, 2021 - 07:34pm

More questions for J&J vaccine boosters ahead of FDA review

Associated Press 13 October, 2021 - 10:55am

WASHINGTON (AP) — The Food and Drug Administration is wrestling with whether and when to offer another dose of the single-shot Johnson & Johnson COVID-19 vaccine, while a new study out Wednesday raises the prospect that using a different brand as the booster might work better.

In an online review posted Wednesday, FDA scientists didn’t reach a firm conclusion about whether there’s enough evidence for J&J boosters, citing shortcomings with the company’s data and little information on protection against the extra-contagious delta variant of the coronavirus.

The review comes ahead of meetings Thursday and Friday when an FDA advisory panel will recommend whether to back booster doses of both the J&J and Moderna vaccines. That’s one step in the government’s vaccine review process: Next week, the FDA will make a final decision on authorizing those boosters and then the Centers for Disease Control and Prevention will debate who actually should get them.

Adding to the complexity is whether it’s OK to use a booster that’s a different brand than someone’s initial shots. Preliminary results of a U.S. government study suggest that mixing and matching boosters will work at least as well — and maybe far better for J&J recipients. Those people had a stronger immune response if they got either a Moderna or Pfizer shot as their booster than if they received another dose of the J&J vaccine, according to results posted online Wednesday. Mix-and-match is also up for discussion by the FDA panel this week.

Health authorities say all the vaccines used in the U.S. continue to provide strong protection against severe disease or death from COVID-19. But amid signs that protection against milder infections may be waning, the government already has cleared booster doses of the Pfizer vaccine for certain people starting at six months after their last shot.

Aiming for uniform recommendations, Moderna likewise asked the FDA to clear its booster dose at six months. But J&J complicated the decision by proposing a second shot over a range of two to six months.

FDA reviewers wrote that a study of the two-month booster plan suggests “there may be a benefit,” while pointing to only small numbers of people who got another shot at six months instead.

Overall, the J&J vaccine “still affords protection against severe COVID-19 disease and death,” the FDA’s reviewers concluded. But data about its effectiveness “are consistently less” than the protection seen with Pfizer and Moderna shots.

For its part, J&J filed data with the FDA from a real-world study showing its vaccine remains about 80% effective against hospitalizations in the U.S.

J&J’s single-dose vaccine was highly anticipated for its one-and-done formulation. But its rollout was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the shot’s benefits outweighed those risks.

Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with those companies’ two-dose shots while less than 15 million Americans got the J&J shot.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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