Dr. Scott Gottlieb might soon be forced to eat his words.
Trial results reported Friday by the Lancet, the British medical journal responsible for publishing some of the earliest research on the coronavirus, found that Russia's Gameleya Institute-developed SARS-CoV-2 vaccine is both effective and safe, though scientists cautioned that long-term study is still required.
The vaccine, the researchers found, produced an antibody response in all test subjects while causing no serious adverse effects. The results mark the latest stamp of legitimacy for the vaccine developed by the world-reknowned Gameleya Institute, and show how the early and intense skepticism expressed by some in the West might have been premature.
The Lancet broke down the results in a series of eight tweets published by its official twitter account.
NEW—Preliminary results from Russian trials find that #COVID19 vaccine candidates led to no serious adverse events and elicit antibody response https://t.co/jGUwQa8oNd— The Lancet (@TheLancet) September 4, 2020
Thread (1/8) pic.twitter.com/NWBpWDvUK3
The new paper reports the findings of two open-label, non-randomised phase 1/2 trials looking at a frozen formulation and a freeze-dried formulation of a two-part #COVID19 vaccine (2/8) pic.twitter.com/fcYqgpjfsl— The Lancet (@TheLancet) September 4, 2020
The two-part #COVID19 vaccine included two adenovirus vectors – recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S) (3/8)— The Lancet (@TheLancet) September 4, 2020
In phase 1 of each trial, individual components of the two-part vaccine (rAd26-S & rAd5-S) were tested for safety— The Lancet (@TheLancet) September 4, 2020
Phase 2 tested whether the vaccine elicited an immune response by giving the full two-part vaccine – rAd26-S was given first, then rAd5-S was given 21 d later (4/8)
The two 42-day trials – including 38 healthy adults each – did not find any serious adverse effects among participants (5/8) pic.twitter.com/IwBnFXcK95— The Lancet (@TheLancet) September 4, 2020
The two 42-day trials also confirmed that the vaccine candidates elicit an antibody response (6/8) pic.twitter.com/dPxWT9CCrL— The Lancet (@TheLancet) September 4, 2020
Secondary outcomes from the trial also suggest the vaccines also produce a T cell and neutralising antibody response within 28 days (7/8) pic.twitter.com/SaszHE9V7f— The Lancet (@TheLancet) September 4, 2020
Large, long-term trials including a placebo comparison and further monitoring, are needed to establish the long-term safety and effectiveness of the vaccine for preventing #COVID19 infection (8/8) https://t.co/EMs2lgWzr9— The Lancet (@TheLancet) September 4, 2020
Russian officials maintain that the vaccine will be made available on an emergency basis in late October or early November. President Trump is desperately scrambling for a US vaccine alternative that can be credibly approved on an emergency basis, so he can say the same.
Meanwhile, in the US...
Read the full Lancet study below: