Calls increase for delaying the second dose of Pfizer, Moderna vax

Atul Gawande

Atul Gawande, M.D., and others are urging that the timing of second dose of the Pfizer and Moderna vaccines be delayed as a way of increasing the number of Americans who are vaccinated against COVID-19. “But we must speed vaccination now. Pushing 2nd doses to 12 weeks like the UK will do that. And I believe the country is ready for it,” Gawande tweeted on Wednesday (March 31). Ezekiel Emanuel and Michael Osterholm are also pushing for a change from the current protocol of giving the shots a month apart. The thinking is that with the risk posed by the variants and a fourth wave, spreading the shots would increase the supply of vaccine that is available for a first shot and would bring the country closer to herd immunity faster.

In a thread on Twitter, Gawande pointed to anMMWR study posted on Monday (May 29) of 3,950 healthcare workers, first responders and other frontline workers who were vaccinated with the Pfizer vaccine (BNT162b2) that showed a single shot was 80% effective against SARS-CoV-2 infections. Two doses bumped up the effectiveness to 90%. Those results are consistent with a study of Israeli healthcare workers vaccinated with the Pfizer vaccine that showed a single dose was 75% effective.

FDA OKs 15 doses of Moderna vax per vial

Another way to increase the supply of vaccine is to increase the number of doses in each vial, so on Thursday (April 2) the FDA announced that the maximum number of doses per vial of the Moderna vaccine could increase to 15. In the same announcement, the agency clarified that prior to this change, the maximum number of extractable doses from Moderna’s vials was 11. “Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly,” said Peter Marks, M.D., Ph.D., director of the agency’s Center for Biologics Evaluation and Research.

An article in Sciencelast week explained that it isn’t just the doses per-vial that matter but also the syringes used to extract those doses. It may take a thinner, nonstandard syringe to eke out extra doses from the Pfizer and Moderna vials (as many as two from Pfizer’s five-dose vials) explained the piece in Science by Sofia Moutinho. “The standard vaccine syringe holds 3 ml, but a thinner, 1-ml syringe is often used for vaccines with small doses, like Pfizer's and Moderna’s. Because it's narrower, the smaller syringe traps less liquid between the plunger and the tip of the needle after a dose is expelled,” reported Moutinho.

157,606,463 and counting

As of yesterday (April 2) at 6 a.m. ET, the CDC’s data show that 157,606,463 vaccine doses have been administered, an increase of 20,921,775 doses, which works out to 15%, from last Friday (March 26). The CDC tally as of yesterday also showed that 30.7% of the U.S. population (101,804,762 people) have been vaccinated, an increase of 12,245,537, or 13.6%, from those who had been vaccinated as of last Friday.

Pfizer vax shows staying power after six months — and against the South African variant

Pfizer and its COVID-19 vaccine partner, BioNTech, announced in a press release early Thursday (April 1) that their vaccine (the two-dose version) was 91.3% efficacious after six months and was 100% effective against the South African variant (B.1.351).

More good news about the Pfizer vax: It’s 100% effective in young adolescents.

This seemed to be Pfizer’s week. On Wednesday (April 1), the company and BioNTech announced that the results of a phase 3 trial among 2,260 adolescents showed that their vaccine was 100% efficacious. According to the press release, 18 cases of COVID-19 were identified in the placebo group of 1,129 study volunteers compared with none in the vaccinated group of 1,131 volunteers. The companies said they would be submitting the data to the FDA and the European Medicines Agency as soon as possible. The positive results increase the possibility that middle school-aged children would be eligible for vaccination when they go back to school in the fall. Some experts say the key to achieving herd immunity is vaccination of children and adolescents, who are not as likely as get seriously ill from COVID-19 as adults but do transmit the disease.

J& J tosses 15 million doses; AP reports that subcontractor has history of shortcomings

Johnson & Johnson announced on Wednesday (April 1) that batch of a key ingredient in its one-shot vaccine had to be thrown out because of quality problems. The company announcement put a positive spin on the situation. Its quality control process had identified “one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to filling and finishing stages of our manufacturing processes,” said the J & J press releasee.

The statement continued, “This is an example of the rigorous quality control applied to each batch of drug substance.”

The Wall Street Journal and other news outlets subsequently reported that the problems at the Emergent BioSolutions facility in Baltimore affected about 15 million doses. The Associated Press reported on Thursday (April 1) that FDA inspection reports it reviewed showed a history of quality and training problems at the Emergent BioSolutions facility.

Vaccine passports: Let debate begin

The Washington Post got ball rolling on the vaccine passport story last Sunday (March 28) with a story that said the Biden administration and private companies are “working to develop a standard way of handling credentials — often referred to as “vaccine passports” — that would allow Americans to prove they have been vaccinated against the novel coronavirus as businesses try to reopen.” On Monday, White House senior adviser Andy Slavitt and Press Secretary Jen Psaki emphasized that the government wouldn’t be issuing the so-called passports but providing guidance. Some states are already issuing passport-like apps. In March, New York state began using an app developed by IBM it is calling the Excelsior Pass that taps the state’s vaccine registry.

On Wednesday, the New England Journal of Medicine published an opinion piece by Mark Hall, J.D., and David Studdert, Sc.D., L.L.B., M.P.H., that outlined some of the ethical and policy issues with vaccine passports. Chief among them is that while vaccine supplies are limited, the passports would further reward privilege and possibly worsen disparity and discrimination along racial and other lines. However, they draw a distinction between government-issued passports and letting private sector business set passport rules. “Allowing sports leagues, concert and sporting venues, clubs, restaurants, and bars some latitude to set the rules that determine access on the basis of customers’ vaccination status would be reasonable,” wrote Hall and Studdert.

CDC Director Walensky’s bumpy-ride week: “impending doom” and walk back of vaxed don't carry the virus

Rochelle Walensky

CDC Director Rochelle Walensky may become more guarded in her statements after being in the news this week — and not in a particulary good way. It start on Monday (March 29) with a CDC video statement during which Walensky went over the dry numbers of rising COVID-19 cases and hospitalizations. Then she went into an emotional, personal aside: “I am going to pause here. I am going to lose the script, and I am going to reflect on the recurring feeling I have of impending doom.” Walensky then pivoted to a more positive message (“we have so much to look forward to, so much promise and potential…”) before saying “but right now I am scared.” Although it is clear that she is talking about a feeling, not the course of the pandemic itself or the Biden administration’s response, that nuance is hard to capture in a news story, let alone a headline or a tweet. The “impending doom” soundbite stuck to Walensky all week.

Later on Monday, Walensky said during an interview on the Rachel Maddow show (according to a transcript of the show posted online) that “vaccinated people do not carry the virus, don’t get sick and that it’s not just in the clinical trials but it’s also in real-world data.” Experts pounced on the “vaccinated people do not carry the virus” part of that statement — and on Thursday (April 1), the New York Times characterized the CDC as “walking back” Walenksy’s statement in a story headlined, “Can Vaccinated People Spread the Virus? We Don’t Know, Scientists Say.”