Biden agreed to waive vaccine patents. But will that help get doses out faster?

“The Biden administration has announced that it will work with the World Trade Organization (WTO) to negotiate a deal to suspend intellectual property rights associated with the Covid-19 vaccines — a surprise move for the administration, which had initially resisted taking such a step.”

“There is unanimous agreement on one thing: There is a lot of work to be done to speed up vaccine manufacturing and vaccinate the world. As the WTO’s General Council meets this week, patents have risen to the top of the agenda. India and South Africa have asked the WTO to waive intellectual property (IP) rules relating to the vaccines so that more organizations can make them.
The case for waivers is simple: Waiving IP rights might enable more companies to get into the vaccine-manufacturing business, easing supply shortages and helping with the monumental task of vaccinating the whole world. The case against them: Taking IP rights from vaccine makers punishes them for work that society should eagerly reward and disincentivizes similar future investment. Opponents have also argued this step would do very little to address the vaccine supply problem, which has largely been the result of factors such as raw material shortages and the incredible complexity and tight requirements of the vaccine-manufacturing process.”

“debates over intellectual property can also distract the world from the policy measures that could really end the pandemic: building our vaccine-manufacturing capacity, committing to purchase the doses the rest of the world needs, and working directly with manufacturers to remove every obstacle in their path.”

“Experts I spoke with emphasized that, generally speaking, the world’s entire supply of critical raw materials is already going into vaccines, and there are no factories “sitting idle” waiting for permission to start making them. What’s more, changing a factory’s processes to produce a new kind of vaccine is a difficult, error-prone process — which went wrong, for example, when a plant converted to make Johnson & Johnson vaccines spoiled millions of doses.

Moderna is an instructive example here. The pharmaceutical company made a splashy announcement in the fall that it would not enforce its Covid-19 vaccine patents. Despite that move, there is still no generic Moderna vaccine, and none of the experts I talked to believed one was on the horizon. (It turned out well for Moderna — get the PR bump from the announcement without suffering the financial drawbacks.)”

“Although the Biden administration’s announcement is a win for the pro-waiver side, the US isn’t the only country that needs to be persuaded for the WTO to agree on a patent waiver. For their part, the EU, the UK, Japan, and Switzerland have expressed opposition. But the US is influential in these debates, and the Biden administration’s about-face may well be decisive.”

Kids Can’t Get The COVID-19 Vaccine Yet. How Much Of A Risk Do They Pose To The Rest Of Society?

“Young children do transmit the virus, and variants like the more-transmissible B.1.1.7 lineage increase how likely kids are to spread COVID-19. It’s also important to note that those low rates of children transmitting COVID-19 are very dependent on behavioral modifications — in particular, wearing masks indoors. A brand-new study out on Thursday found that risk-reduction strategies like teachers wearing masks, kids wearing masks, checking symptoms daily and canceling extracurricular activities like sports made the difference between in-person schooling that spread COVID-19 from kids through their families and in-person schooling that didn’t significantly increase the spread of COVID-19.”

“kids going unmasked outdoors — unless they’re in a large, closely packed group — is probably fine. But masking indoors remains an important way to keep COVID-19 from spreading among unvaccinated people of all ages.”

3 reasons most public masking is still important — even if you’re vaccinated

“We know the vaccines authorized in the US are extremely effective and safe — but not perfect — at preventing Covid-19 illness. Newer data suggests they are also very good (though also not perfect) at keeping people from getting infected, thus likely drastically reducing the chances they could spread it to others.

Even with the small risks of these “breakthrough infections,” there are much more pressing reasons to keep masking in public — especially indoors in places like gyms, stores, and airports — and, according to the new CDC guidance, in most outdoor gatherings as well. Masking remains one of the least intrusive interventions we can take to keep putting the brakes on Covid-19 spread.

From variant wild cards to protecting unvaccinated kids, the reasons we should keep masking in crowded public spaces at least into the summer are strong. We talked to experts to better understand them and to get a glimpse of when we might finally be able to leave our masks at home.”

“The majority of people in the US are still susceptible to infection from Covid-19. “There are folks around us who will not or cannot get the vaccine, and we have to keep thinking, as a community, of ways to protect them, too,””

“a subset of people — roughly 3 percent in the US — have compromised immune systems that might do a poor job of mounting a robust response to the vaccine, leaving them vulnerable to infection even after getting shots.

There are also some people who aren’t able to wear masks to protect themselves in public. This includes some adults and children with disabilities or rare health conditions, as well as babies and toddlers”

“Although the vaccines authorized for use in the US appear to be very effective against the variants that are circulating, it is possible future strains will be better at evading vaccine protection (as the B.1.351 variant, first detected in South Africa, is against the AstraZeneca/Oxford vaccine). Vaccine companies are working to keep pace with variants, testing their vaccines against them and formulating potential boosters. But, says Guthrie, “it may be a bit of a game of whack-a-mole as new variants come up.””

““These variants — especially ones that have mutations that make them more transmissible — can pop up and then spread quite quickly,” Guthrie says. “If you combine that with a variant that could evade the current vaccines, you’re not going to get a lot of advance warning.” Which means a widespread outbreak, including some people who had already gotten their shots, could get going before we were able to contain it.

Masking can not only prevent a new variant from spreading but could also help prevent new variants from emerging, as the more people the virus infects, the greater the opportunity it has to mutate.”

“Even if we can’t drop our masks indoors for a little while longer, outdoors is a different story. The rates of public outdoor transmission of Covid-19 are incredibly low, and most known cases of outdoor infection spread have occurred from long conversations, yelling, or exercising together.”

Why Johnson & Johnson shots were paused — and why that’s so confusing

“Both the Food and Drug Administration and the Centers for Disease Control and Prevention recommended a pause in distributing the vaccine after six reported cases of cerebral venous sinus thrombosis (CVST). These clots block blood flowing out of the brain and can quickly turn deadly.

The complications were found in women between the ages of 18 and 48, and they arose between six and 13 days after receiving the Johnson & Johnson vaccine. “Of the clots seen in the United States, one case was fatal, and one patient is in critical condition,” said Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, during a Tuesday press conference.”

“For regulators, the episode highlights the tricky challenge of balancing caution against an urgent need for a vaccine in a still-raging pandemic. And as they investigate the problem, they also have to try to maintain public confidence in the vaccination program. The pause helps show that regulators are taking potential problems seriously, but if they botch the messaging, that could make people less likely to get vaccinated.”

“there are several factors that made regulators pay close attention to the recent cases following vaccinations with the Johnson & Johnson shot. Marks explained that patients with these clots also had thrombocytopenia, a condition where platelets in the blood drop to very low levels, leading to bleeding and bruising. The combination of blood clots and low platelets means that patients cannot receive conventional blood clot therapies like heparin, a blood thinner. That’s why health officials want to wait to resume vaccinations with the Johnson & Johnson vaccine until they can investigate the concern and come up with new guidelines if necessary.

Another factor is that these cases occurred in younger women, who normally don’t face a high risk of these types of clots.”

“when vaccines make the jump from thousands of carefully screened trial participants to millions of people in the general population, rare problems — the one-in-a-million complications — start to emerge.”

“Regulators could, then, take a similar approach with the Johnson & Johnson shot to the one they used for allergies and the mRNA vaccines, adding a screening criterion for people at highest risk of these blood clots before they receive the Johnson & Johnson vaccine.”

Cuomo’s Vaccine ‘Fix’ Is Still a Tangled Mess of Rules, Restrictions, and Fines

“Cuomo presented area hospitals with a double bind: Fail to use all of your vaccines and be fined up to $100,000, or vaccinate people out of order and be fined $1,000,000. Inoculating health care workers first may sound sensible on the surface, but that evaporates when you consider that logistical externalities often prevent providers from corralling such employees in perfect time. (The Moderna and Pfizer vaccines can last for several months while frozen, but after thawing they have a very short shelf-life.) If those hospitals strayed and found an alternative candidate outside the mandated plan, they would have met financial ruin.

That threat is not an empty one: At least one hospital is under investigation for daring to vaccinate school officials before their time came.

Cuomo has claimed that such rules are necessary to prevent shady providers from constructing vaccine bribery schemes and pushing their friends to the front of the line. That concern may not be utterly groundless, but there is no evidence of widespread inoculation fraud. Compromising the health of New Yorkers seems an inept response to a negligible risk. The benefit of keeping the state’s senior citizens alive surely trumps such a worry.

New York’s graduation to tier 1b is a step in the right direction—now 3.2 million more people can receive the vaccine without health care providers worrying about their careers ending. But the state is still excluding large swaths of senior citizens in favor of “critical infrastructure workers,” such as grocery attendants. Those workers are providing a vital service, but many are also young and healthy, with much less risk of dying should they contract COVID-19.”

“people have been known to ghost their vaccine appointments even as doses are nearing expiration, something that no health practitioner can foresee. As I wrote last week, the D.C. Department of Health permits providers to pull aside any willing recipient if they have surplus vaccines that would otherwise go to waste. New York’s regulations on who may benefit from those extra doses will likely still cause some to end up in the trash.”

Vaccines Are 100% Effective at Preventing COVID-19 Hospitalizations and Deaths

“What the 95 percent figure really means here is that vaccinated people in the clinical trials had a 95 percent lower risk of getting COVID-19 compared with the unvaccinated control group participants. That means that vaccinated people were 20 times less likely than the control group to get COVID-19.”

” There is even more good news about COVID-19 vaccine efficacy. As LiveScience reports, the Pfizer/BioNTech, Moderna, and Johnson & Johnson clinical trials all found that their vaccines were essentially 100 percent effective in preventing severe disease six to seven weeks after trial participants had received a first/single dose. As biotech journalist Anna Nowogrodzki notes, “Zero vaccinated people in any of the trials were hospitalized or died of COVID-19 after the vaccines had fully taken effect.” Now that’s the kind of vaccine efficacy that we can all cheer.”

Why We Can’t Make Vaccine Doses Any Faster

“Vaccine supply chains are extremely specialized and sensitive, relying on expensive machinery, highly trained staff and finicky ingredients. Manufacturers have run into intermittent shortages of key materials, according to the U.S. Government Accountability Office; the combination of surging demand and workforce disruptions from the pandemic has caused delays of four to 12 weeks for items that used to ship within a week, much like what happened when consumers were sent scrambling for household staples like flour, chicken wings and toilet paper.

People often question why the administration can’t use the mighty Defense Production Act — which empowers the government to demand critical supplies before anyone else — to turbocharge production. But that law has its limits. Each time a manufacturer adds new equipment or a new raw materials supplier, they are required to run extensive tests to ensure the hardware or ingredients consistently work as intended, then submit data to the Food and Drug Administration. Adding capacity “doesn’t happen in a blink of an eye,” said Jennifer Pancorbo, director of industry programs and research at North Carolina State University’s Biomanufacturing Training and Education Center. “It takes a good chunk of weeks.”

And adding supplies at any one point only helps if production can be expanded up and down the entire chain. “Thousands of components may be needed,” said Gerald W. Parker, director of the Pandemic and Biosecurity Policy Program at Texas A&M University’s Scowcroft Institute for International Affairs and a former senior official in the Department of Health and Human Services office for preparedness and response. “You can’t just turn on the Defense Production Act and make it happen.”

The U.S. doesn’t have spare facilities waiting around to manufacture vaccines, or other kinds of factories that could be converted the way General Motors began producing ventilators last year. The GAO said the Army Corps of Engineers is helping to expand existing vaccine facilities, but it can’t be done overnight.

Building new capacity would take two to three months, at which point the new production lines would still face weeks of testing to ensure they were able to make the vaccine doses correctly before the companies could start delivering more shots.”

“The Trump administration deployed the Defense Production Act last year to give vaccine manufacturers priority in accessing crucial production supplies before anyone else could buy them. And the Biden administration used it to help Pfizer obtain specialized needles that can squeeze a sixth dose from the company’s vials, as well as for two critical manufacturing components: filling pumps and tangential flow filtration units.”

Why Israel is leading the world in vaccinating its population

“Netanyahu declared that Israel will be a “global model state for the rapid vaccination of an entire country.” But how much Israel’s success can be replicated abroad is hard to say. Israel’s small and densely packed population has eased some of the logistical and operational challenges of delivering the vaccine. And Israel’s universal health care system, which has easily accessible records for all citizens, has massively facilitated the program.”