All adults eligible for vaccine as state targets full reopening

Update: Marin County has paused local use of the Johnson & Johnson vaccine at the request of U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration following a report of six cases of an "extremely rare" type of blood clot in individuals who received the J&J COVID-19 vaccine.

The county says it will store all available supply until the FDA and CDC conclude their investigation of the product.

In Marin, the J&J vaccine accounts for less than 3 percent of the cumulative vaccine allocation, and the temporary halt will mainly impact mobile operations, where the single-dose vaccine increased capacity and could better inoculate underserved and transient communities in which residents may not be as reachable for the second dose required of the Pfizer and Moderna vaccines.

The J&J-related blood clots occurred among women ages 18-48, six to 13 days after vaccination; one died, and another is in critical condition. The symptoms included severe headache, abdominal pain, leg pain and shortness of breath.

Those cases were seen in just six of more than 7.1 million doses, or fewer than one in 1 million (0.00008%). Roughly 1 million women in the affected age group have received the J&J vaccine, for a rate of six in 1 million (0.0006%) among women 18-48. By comparison, the risk of the same type of blood clot — a brain clot called central venous sinus thrombosis, or CVST — is already two to 14 in 1 million (0.0002-0.0014%) in the general population, according to the CDC and Johns Hopkins University.

For all types of blood clots — including brain clots, as well as deep-vein thrombosis that can travel to the lungs to create a pulmonary embolism — the risk is up to 500 in 1 million for women not on birth control (0.05%), increasing to as many as 10,000 out of 1 million over 10 years for women on birth-control (1%). ICU patients with severe COVID-19 experience clots at a rate of 310,000 out of 1 million (31%).

The FDA and CDC concern is based is part on the rare combination of the brain clot with low platelet levels, which has made heparin — a blood thinner used to treat clotting — a potentially dangerous treatment that requires alternatives. Those experiencing symptoms within three weeks of receiving the J&J vaccine should contact their health-care provider.

Read the FDA statement:https://www.fda.gov/.../joint-cdc-and-fda-statement... Read the Marin Health statement: https://www.marincounty.org/.../2021/hhs-covid-jjvax-041321

All Californians 16 and older are eligible for the coronavirus vaccine starting tomorrow, April 15, a massive step toward Gov. Gavin Newsom’s plan to fully reopen the state exactly two months later and just as the U.K. variant of the disease has been detected in Marin for the first time.

However, Marin officials warn that despite the new vaccine eligibility — no vaccine in the U.S. is authorized for those younger than 16, and those 16-17 may only receive the two-dose Pfizer vaccine — the county continues to face supply shortages and that it could take three to four weeks before residents can get an appointment.

Kaiser Permanente on April 13 was to close its mass-vaccination site in the Terra Linda High School gym and join the county at the Marin Center, creating a “vaccine super site” there by increasing capacity to 3,600 daily doses from 2,500. Dr. Matt Willis, the county’s public-health officer, said last week that while Marin has the capacity to give 6,000 doses a day across its mass-vaccination sites and mobile units, it’s only receiving about 3,000 doses per day.

That will be reduced further this week after a mix-up by a Baltimore manufacturing contractor earlier this month spoiled 15 million doses of the one-dose Johnson & Johnson vaccine. However, Willis said he’s still hopeful there will be enough supply to inoculate all willing Marin adults by early May, nearly two months before the national goal of Independence Day.

As of The Ark’s press deadline, more than 68 percent of all Marin adults had received at least one dose, with nearly 45 percent fully vaccinated. The public-health goal is to reach at least 80-percent vaccination to provide herd immunity for those who cannot be vaccinated for medical reasons. That goal could butt up against the 20-percent hesitancy rate among Americans, with 7 percent saying they would only get the vaccine if required and 13 percent saying they would definitely not get the vaccine, according to the March results of the Kaiser Family Foundation’s monthly survey.

On April 6, Newsom announced that California plans to “turn the page” on the four-tier, color-coded blueprint for reopening the economy, saying the state will fully reopen economic activities on June 15 as vaccine supply meets demand and hospitalization rates remain stable and low.

However, Newsom said face-covering requirements will remain in place even after the reopening, and that proof of vaccination or negative test results will remain for some settings.

Marin remains in the third, or orange, tier of the state’s blueprint, with its rolling seven-day adjusted daily new-case rate rising to 3.4 per 100,000 residents April 6 from 3.1 the prior week, where a rate of less than 2 per 100,000 is required to advance to the yellow tier and further reopen the economy. Marin’s test positivity, at 1.2 percent, and health-equity test positivity, at 1.8 percent, are both already at yellow-tier levels.

“The way to earn that (yellow) status will be for people to cover their faces, not to travel, not gather together indoors,” Willis said recently. “It’s inconsistent if people think they can engage in those behaviors and also hope to achieve the yellow tier. Those things will not happen at the same time.”

That statement came before two cases of the B.1.1.7 variant of SARS-CoV-2, the virus that causes COVID-19, were found in Marin. The variant, which is more contagious than the original strain and may lead to more severe disease, is driving a surge in new cases across Europe and the eastern U.S. and has been detected elsewhere across California.

“The good news is the current COVID-19 vaccines are effective against the B.1.1.7 strain,” Willis said in an April 6 press statement announcing the discovery.

California has its own variant, B.1.427/B.1.429, which has also been deemed a “variant of concern” by the U.S. Centers for Disease Control and Prevention and has become the predominant form of the virus found in Marin. Again, however, all three of the currently authorized vaccines appear to be 100 percent effective in preventing intensive-care-unit hospitalization and death from the original strain and its California variant.

Others strains include the South African B1.351 strain and Brazilian P.1 strain, neither of which have been detected in Marin. A new study by researchers at Tel Aviv University and Clalit, the largest health-care organization in Israel, suggests the South African variant can “break through” the two-dose Pfizer vaccine but that more research is required; that study has not yet been peer reviewed.

CDC Director Dr. Rochelle Walensky last month said she is worried about the spread of variants in the U.S. leading to a new surge and increase in hospitalizations — a concern that has been echoed locally by Willis.

“It’s a reminder as we reopen that we’re not out of the woods, by any means,” he said last week. “We need to stick with the tried and true prevention measures while we work to increase vaccination rates.”