A Third U.S. Vaccine Is on Its Way
A roundup of the most important Covid-19 vaccine news this week
There are still 20 vaccines in phase 3 trials, eight approved for limited use — Bahrain granted emergency approval to Johnson & Johnson’s vaccine this week — and four approved for full use in some countries. The fully approved vaccines include those from Pfizer/BioNTech, Sinopharm, Sinovac, and Moderna.
The big vaccine news this week is that Johnson & Johnson’s vaccine is poised to receive emergency use authorization in the United States following today’s Food and Drug Administration (FDA) advisory panel meeting. In Africa, the rollout of the United Nations-backed COVAX effort to distribute vaccines to less wealthy countries began.
Vaccines are being rolled out in many nations, but access to vaccines and vaccination rates vary widely around the world. Many countries have not vaccinated a single person yet. Israel, with 35.8% of its population fully vaccinated, is the leader in the global rollout, followed by Seychelles and Serbia. The United States is fourth, with 6.5% of its population fully vaccinated (down from third place last week). The vast majority of countries, however, have not yet received any vaccines.
FDA releases positive analysis on Johnson & Johnson’s vaccine
On Wednesday, the FDA released an analysis showing that Johnson & Johnson’s vaccine is safe and effective. The overall effectiveness of the vaccine in the United States was 72%, and in South Africa, where a more transmissible variant has been circulating, its overall effectiveness was 64%. Johnson & Johnson’s vaccine is highly anticipated because it doesn’t require regular refrigeration and is administered in only one dose, unlike the Pfizer and Moderna vaccines. Today, experts from outside the FDA will decide whether to recommend the vaccine for emergency use authorization in the United States.
Pfizer’s vaccine doesn’t have to be kept in ultracold temperatures anymore
On Thursday, the FDA announced that Pfizer’s vaccine can be stored at normal freezer temperatures — a promising departure from the original protocol, which required that the vaccine be stored at ultracold temperatures of -80ºC to -60ºC (-112ºF to -76ºF). The requirement for ultracold storage was considered one downside of Pfizer’s vaccine because it made storage and administration more complicated. The FDA made its decision in response to data that Pfizer had submitted to the agency last week.
FDA speeds up testing protocol for vaccines adapted to variants
Vaccine manufacturers have been racing to adapt vaccines to the new, more transmissible variants in circulation, but these new vaccines must still pass an FDA review in order to be used. To speed up this process, which normally is quite slow, the FDA released new guidance on February 22 outlining a modified review procedure that doesn’t require long, randomized controlled trials. As the New York Times noted, the recommendations suggest using small trials like those used for annual flu vaccines.
The COVAX rollout begins
On Wednesday, the long-awaited rollout of COVAX, the UN-backed initiative to procure and distribute vaccines to lower-income countries, began in Ghana. COVAX receives funding and donations of vaccines from wealthy countries and also aims to buy doses in bulk directly from vaccine manufacturers: The United States, for one, has committed to $4 billion in funding to COVAX, and U.S.-based vaccine manufacturer Novavax has pledged to sell 1.1 billion doses to COVAX. It has been slow, however, to get off the ground. As AP notes, COVAX has been strapped for cash and unable to procure vaccines in part because wealthy countries have bought up most of the supply. Experts like Craig Spencer, MD, MPH, have pointed out that it’s critical to get everyone on the planet vaccinated because doing so is the only way to prevent the emergence of new variants.